Role OverviewThe QA Specialist II performs day-to-day activities to ensure drug substances comply with FDA and international regulatory requirements. They review and process GMP documents, provide cGMP guidance, and support customer and regulatory audits.
What You Will Do
Perform production room, dispensary, and shipment clearance verifications, revise SOPs, manage GMP documentation, verify scans, and coordinate quality events.
Why It Might Be a Fit
Requires 3-5 years of experience in Quality Assurance and/or Quality Control, internal auditing, and working with regulatory agencies. Knowledge of cGMP, FDA regulations, and Quality Management Systems is necessary.
Requirements
- Bachelor's Degree in organic chemistry or related field
- 3-5 years experience in Quality Assurance and/or Quality Control
- 3-5 years experience in internal auditing and working with regulatory agencies
- Ability to review scans of BPRs and chromatograms with high accuracy
- Knowledge of cGMP and FDA regulations and guidance(s)
- Knowledge of Quality Management Systems
- Knowledge of GxP
- Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint
Benefits
- Competitive pay
- Annual performance bonus
- Comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- Paid vacation, personal, and sick days
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