Cell Therapy Specialist I – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist I is part of the NK cell therapy manufacturing team. The position will be expected to support the successful tech transfer and operational readiness process.  The CTS I will use knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS I will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Routine monitoring of equipment
  • Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
  • Must follow special cleaning and gowning procedures for the facility.  Required to work in cleanroom environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
  • Perform error free calculations of cell concentrations, dilutions, viabilities during production
  • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
  • Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
  • Maintains current inventory of supplies
  • Other duties as assigned

Job Qualifications

  • Education: Bachelors in relevant science or engineering discipline
  • 1-3 years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

Cell Therapy Specialist II – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist II is part of the NK cell therapy manufacturing team. The position will be expected to support the successful tech transfer and operational readiness process.  The CTS II will use knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS II will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Routine monitoring of equipment

Job Qualifications and Skills

  • Education: Bachelors in relevant science or engineering discipline
  • 2-5 years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

Cell Therapy Specialist III – FT – Santa Ana, CA

Job Summary

The Cell Therapy Specialist III is a manufacturing subject matter expert (SME) for the NK cell therapy manufacturing process.  The position will be expected to support the successful tech transfer and operational readiness process.  The CTS III will use expert knowledge of cGMP regulations and project management to ensure manufacturing readiness.  Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance.  Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies.  Upon start of clinical manufacturing the CTS III will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.

General Accountabilities

  • Performing patient process unit operations and support operations described in standard operating procedures and batch records
  • Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
  • Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
  • Timely completion of training assignments to ensure the necessary technical skills and knowledge
  • Assisting in setting up manufacturing areas and equipment.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Work with management to establish and maintain daily unit operations schedule that includes people, product, and material flow across multiple shifts
  • Routine monitoring of equipment
  • Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
  • Must follow special cleaning and gowning procedures for the facility.  Required to work in cleanroom environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
  • Perform error free calculations of cell concentrations, dilutions, viabilities during production
  • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
  • Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
  • Maintains current inventory of supplies
  • Other duties as assigned

Job Qualifications and Skills

  • Education: Bachelors in relevant science or engineering discipline
  • 5+ years of experience in a cGMP biologics or cell therapy manufacturing
  • Preferred record of leading and training manufacturing staff
  • Cell culture processing experience in handling and propagation of human primary cell
  • Aseptic processing in ISO 5 biosafety cabinets
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
  • Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
  • Ability to work off-shift and long hours as required
  • Ability to lift over 30lbs

 

Clinical Laboratory Supervisor – FT – Santa Ana, CA

Job Summary

Under the direction of Director of Lab Operations, the lab supervisor would provide day-to-day supervision of testing schedule and reporting of test results. The clinical Laboratory Supervisor is also responsible for validating and implementing new developed assays according to clinical laboratory protocol. He/she would maintain clinical laboratory quality assurance protocol in compliance to CLIA and CAP regulation and accreditation requirements. In addition, the lab supervisor will assist in establishing new client’s facility setup and continue support to clinical trial projects within the company. The position is best suited for a candidate who can efficiently work in a diverse laboratory environment, goal-oriented laboratory services setting.

 

General Accountabilities, demonstrating the ability to perform the following capabilities:

  • Strong technical background on chemistry, immunophenotyping and molecular assays using various methods including flow cytometry, ELISA, qPCR in clinical laboratory settings.
  • Experience on validate and implement laboratory developed clinical test
  • Establish and maintain clinical laboratory quality assurance protocol
  • Ensure proper performance of laboratory procedures and quality assurance standards
  • Documentation of QA process in relate to all aspects within laboratory
  • Assessment of staff performance and ensure high quality test result with satisfaction turnaround time
  • Provide troubleshooting of laboratory instrumentation and methodologies concerns
  • Interact with vendors and manufacturers regarding technical assistance.
  • Monitor and maintain acceptable levels of analytic performance
  • Provide training and orientation for both licensed and unlicensed lab employees
  • Resolve problems and ensure remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
  • Ensures all procedures and practices of phlebotomy services compliance to blood draw requirements and regulations
  • Coordinates, setup and continue monitor for offsite specimen collection and training at clients’ facilities
  • Maintain satisfaction services to clients in relate to test results and promptly attends to clients concerns and questions.
  • Manage the logistic and pickup schedules for specimen shipping and transportations
  • Identify training needs and assures all lab personnel receive regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
  • Evaluate the competency of all testing personnel and assures the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
  • Review worksheets, test results, quality control records, proficiency testing results, and preventive maintenance records.
  • Monitor performance of instrument maintenance and function checks.
  • Assess test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
  • Evaluate and document the performance of individuals responsible for high complexity testing at pre-determined interval.
  • Create, reviews and revises Standard Operating Procedures, with periodic updates, to ensure Lab Director review and approval for all new and/or revised procedures.
  • Ensure that QC is within appropriate limits and that all test results are accurate, performing weekly QC reviews as required.
  • Oversee the inventory and ordering of supplies process.
  • Maintain the performance and recording of Proficiency Testing.
  • Manage schedules and maintain complete coverage of all shifts in the laboratory.
  • Perform assessment of the operation of all instruments in areas of responsibility and assign maintenance procedures or repairs as needed.
  • Ensure all lab equipment is always calibrated and functioning effectively.
  • Ensure that the records are organized, neat and readily retrievable.
  • Ensure that all specimens are organized and readily retrievable.
  • Meet target dates and due dates for completion of tasks.
  • Ensure that the lab is organized, neat and clean.
  • Provide back up to any technical or clerical position as needed.
  • Thorough understanding and experience in managing CLIA and CAP laboratory in compliance to regulatory and accreditation requirements
  • Review, implement and monitor lab protocols to ensure continue laboratory operation of high-quality standards
  • Maintain a safe laboratory environment in compliance with OSHA and CLIA regulations
  • Assign priority and CLS functions in the laboratory, performing all analytical procedures, to include specifically:
  • Prepare all solutions, such as, calibrators, etc. either by automation or manual pipetting techniques.
  • Calibrations and Quality Controls
  • Specimen preparations that require dilutions and pipetting techniques
  • Loading samples onto all high complexity testing processes
  • Reviewing, approving and releasing all QC and patient results
  • Troubleshoots problems (client, instrument, computer) as needed.
  • Perform any other duties as assigned by the Director of Laboratory Operations
  • Excellent verbal and written communication skills.
  • Demonstrate critical analysis and complex problem-solving skills.
  • Demonstrate ability to manage highly confidential and proprietary information.
  • Excellent organizational skills
  • Proficient in computer skills that include spreadsheets and word processing software, and Microsoft Office required.
  • Ability to perform complex lab tasks and maintain patient confidentiality.
  • Complies with applicable legal requirements, standards, and procedures including, but not limited to, those within the Compliance Process, Code of Conduct, HIPAA, State, CAP and CLIA.
  • Provides leadership and support for the Compliance process within management area.
  • Ensures timely and accurate reporting and responses to compliance-related issues and assists with implementation of corrective action plans related to such issues.
  • Reports concerns and suspected incidences of non-compliance to Lab Director.
  • Provides open lines of communication regarding compliance issues within management areas and ensure that retaliation against staff who report suspected incidences of non-compliance does not occur.
  • Participates in monitoring and auditing activities and investigations, and implementing quality improvement processes, as required.

NOTE: The above statements are intended to describe the general nature and level of work performed by an employee in this position. They are not intended to be construed as an exhaustive list of all tasks and responsibilities required. All employees may be required to perform duties outside of their normal responsibilities from time-to-time, as needed.

Job Qualifications

  • Education:
    • BS / BA degree in Science required.

    Experience:

    • Minimum eight (8) years of clinical laboratory required.

    License/Certification:

    • Current California State License for Clinical Laboratory Scientist required.
    • ASCP certification from the American Society for Clinical Pathology preferred.

Skills

  • Proficient in Microsoft word and Excel
  • Excellent critical thinking and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Excellent organizational skills

Quality Assurance I – FT – Santa Ana, CA

Job Summary

  • Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
  • Work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
  • Perform other duties as assigned.

General Accountabilities

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
  • Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
  • Possible contact with human blood and human blood base product.Other duties as assigned.

Job Qualifications

  • Education: Bachelor’s degree in biochemistry or related biological field and minimum of 3-5 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience. Master’s degree in a related science for a minimum of 4 + years a highly preferred.
  • Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, CAPA, as well as with internal and external audits.
  • Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
  • Highly detail oriented and excellent interpersonal skills within collaborative work environment.
  • If required, ability to work on weekend, off-shift and long hours.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strict adherence to SOP’s and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
  • Self-motivated and willing to accept responsibilities outside of initial job description.
  • Ability to lift over 30lbs.

Skills

  • Excellent technical skills; Microsoft Word, Excel and Data Analysis.
  • Exceptional time management, problem solving and organization skills.
  • Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.

Quality Assurance II – FT – Santa Ana, CA

Job Summary

  • Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
  • Own and/or approve change controls to manage new materials and material changes.
  • Develop and assist in maintaining the audit schedule and approved supplier list for assigned suppliers.
  • Perform ongoing evaluation of quality systems, that include but are not limited to, the quality audit program, vendor qualification system & the corrective action program.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on quality related matters, as needed.
  • Perform other duties as assigned.

General Accountabilities

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Generates COAs for product release.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices.
  • Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
  • Work in clean room environment that requires specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
  • Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria.
  • Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
  • Handle human blood and human blood base product.
  • Other duties as assigned.

Job Qualifications

  • Education: Bachelor’s degree in biochemistry or related biological field and minimum of 3-5 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience. Master’s degree in a related science for a minimum of 4 + years highly preferred.
  • Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, and CAPA as well as with internal and external audits.
  • Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
  • Highly detail oriented and excellent interpersonal skills within collaborative work environment.
  • If required, ability to work on weekend, off-shift and long hours.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strict adherence to SOP’s and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
  • Self-motivated and willing to accept responsibilities outside of initial job description.
  • Ability to lift over 30lbs.

Skills

  • Excellent technical skills; Microsoft Word, Excel and Data Analysis.
  • Exceptional time management, problem solving and organization skills.
  • Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.

Quality Assurance III – FT – Santa Ana, CA

Job Summary

  • Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Work with Manufacturing, Clinical Development and Quality Control as area Quality Assurance (QA) representative.
  • Provide quality assurance input and oversight in resolving manufacturing and quality operations-related issues.
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area.
  • Perform audits of raw materials and component suppliers. Work with suppliers to identify and implement responses to observations. Write audit reports and close records within target timelines.
  • Own and/or approve change controls to manage new materials and material changes.
  • Develop and assist in maintaining the audit schedule and approved supplier list for assigned suppliers.
  • Perform ongoing evaluation of quality systems that include, but are not limited to the quality audit program, vendor qualification system & the corrective action program.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on quality related matters, as needed.
  • Develop & manage company standard operating procedures & company wide quality policies.
  • Develop, perform and/or oversee equipment IQ/OQ and PQ.
  • Perform other duties as assigned.

General Accountabilities

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Generate COAs for product release.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices.
  • Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
  • Work in clean room environment, which requires specialized gowning, such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
  • Maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria.
  • Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
  • Able to handle human blood and human blood base product.
  • Other duties as assigned.

Job Qualifications

  • Education: Bachelor’s degree in Biochemistry or related biological field and minimum of 5-6 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience.
  • Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, CAPA, as well as with internal and external audits.
  • Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
  • Highly detail oriented and excellent interpersonal skills within collaborative work environment.
  • If required, ability to work on weekends, off-shift and long hours.
  • Comfortable in a fast-paced, small company, environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strict adherence to SOP’s and cGMP regulations; the ability to accurately complete documentation associated with clinical manufacturing.
  • Self-motivated and willing to accept responsibilities outside of initial job description.
  • Ability to lift over 30lbs.

Skills

  • Excellent technical skills; Microsoft Word, Excel and Data Analysis.
  • Exceptional time management, problem solving and organization skills.
  • Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.

Quality Control Analyst I – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and must agree to a background check

Quality Control Analyst II – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • Provide training to junior staff.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 3-6 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 2-5 years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and agree to a background check

Quality Control Analyst III – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.

General Accountabilities

  • Function as lead analyst to assist management in coordination of day to day QC activities.
  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • Provide training to junior staff.
  • May perform other duties as assigned.

Job Qualifications and Skills

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 6+ years experience, or Masters Degree in Chemistry, or Biological Sciences, with 5+ years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S. and agree to a background check