Quality Assurance Specialist
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Accentuate Staffing is assisting a rapidly growing pharmaceutical company who is looking for a Quality Assurance Specialist to join their team! This is a direct hire opportunity working 8am-5pm Monday-Friday.
Responsibilities:
- QA Specialist will be responsible for manufacturing, packaging and laboratory testing GMP record review
- QA Specialist will be responsible for product complaint and root cause investigations of deviations impacting the manufacture, testing, storage, or quality of the products or system
- QA Specialist will write SOPs for Quality, Manufacturing, and/or Laboratory processes
- QA Specialist will review executed batch/packaging and laboratory records
- QA Specialist will escalate non-conformance events found during the review and initiate necessary investigations
- QA Specialist will review and approve event notifications and deviations
- QA Specialist will perform detailed investigations of product complaints and deviations observed/assigned to determine root cause
- QA Specialist will prepare reports summarizing manufacturing, investigation, change control, release, and stability test results information required to complete the Annual Product Reviews
Requirements:
- Candidates must have a Bachelors of Science degree in a relevant scientific discipline
- Candidates with a professional certification such as Sig Sigma, Quality Engineer, or Quality Auditor preferred
- Candidates must have 5 years relevant Quality Assurance experience within a pharmaceutical industry working with batch record review, product complaint investigations, root cause analysis, GMP documentation control
- Candidates must have knowledge of CGMP, USP, ICH requirements
