Location: Southern California
Duration: 3-6 Months
The client is looking for a QA specialist (3-5 years experience) to review manufacturing batch records, analytical testing results, and investigation reports for compliance with internal policies and procedures, applicable regulatory guidelines, and phase appropriate CGMPs, with minimal supervision.
- Review and approve new production batch records and completed production batch records.
- Review specifications and stability protocols for accuracy and completeness
- Responsible for reviewing Analytical methods, protocols, and validation reports.
- Responsible for reviewing Quality Events (e.g. deviations, NCMRs, CAPAs, OOSs, and complaints) to ensure appropriate investigations are completed timely.
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 6Ms, 5-Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Review change control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, etc.
- Work with cross functional teams and vendors to ensure timely completion of documentation reviews.
- Perform other duties, as assigned.
- Minimum, Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc)
- Quality professional with a minimum of 3-5 years relevant experience in the biotech industry.
- Requires knowledge of CGMPs regulations (e.g. ICH Q7, Q9, and Q10, 21 CFR 210-211)
- 3-5 years of experience in the Biotech or Pharmaceutical Industry, or relevant comparable background
- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
- Detail oriented with strong analytical, written, verbal communication and interpersonal skills
- Experience with Veeva Vault, Master Control or similar Electronic Data Management Systems preferred.
- Strong background in Good Documentation Practices is required. Must be computer literate.