- 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.
- 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.
- 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.
- 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.