QA Specialist II
3 weeks ago
Pay Rate: $35-45/hour depending on experience.Responsibilities:
- Support clinical product and cell growth media final disposition by reviewing executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures.
- Perform Quality Assurance activities to support Manufacturing operations. For example, perform line clearances, in-process checks, label issuance, batch record issuance, monitoring of labeling activities, cell bank control and issuance, and final product control.
- Perform inspection and release of incoming GMP raw materials according to appropriate material specifications and standard operating procedures.
- Perform document change control activities.
- Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory requirements.
- Prepare and maintain training and competency files.
- Issue equipment use and maintenance logs.
- Write and review investigations and product complaints to determine root cause and identify/implement related CAPA
- Ensure that opportunities for continuous improvements are identified and implement changes to Quality System to support system improvements.
- Participate in regular site and Quality meetings.
- Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel.
- Participate in audits and regulatory inspections as assigned.
- Participate in ensuring the facility is inspection-ready at all times.
- Bachelor’s degree in a biological science, chemistry, or related science field.
- Minimum of 2-4 years of experience in the pharmaceutical / biopharmaceutical industry and 2 years direct experience in QA/QC.
- Good knowledge of biologics cGMP manufacturing ideally including recombinant protein and cell therapy cGMP manufacturing.
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