Role OverviewThe QA Specialist I in Finishing Operations supports the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provides quality oversight for terminal sterilization, visual inspection, labeling and packaging of parenteral drugs. Performs the quality release of incoming materials. Reviews documentation and quality records.
What You Will Do
Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations. Review executed batch records and other associated controlled documents. Perform clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation.
Why It Might Be a Fit
Must have proficient computer skills in Microsoft Word, Excel, and Outlook. Must have basic computer skills such as Microsoft Word, Excel and Outlook. Bachelor’s degree in Life Sciences or related field preferred. Experience working in a pharmaceutical or other regulated environment preferred.
Requirements
- 1-2 years related work experience
- Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
- Proficient computer skills in Microsoft Word, Excel, and Outlook
- Basic computer skills in Microsoft Word, Excel, and Outlook
Benefits
- Medical insurance
- Prescription insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability benefits
- 401(k) program with 100% vesting
- Paid volunteer time
- PTO
- Wellness time off
- Paid holidays
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