- 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.
- 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.
- 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.
- 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.