Related skills
qa gmp sop qms fda📋 Description
- Prepare for inspections by state boards, DEA, FDA, and accreditors.
- Conduct internal QA audits; support external audits and regulatory inspections.
- Develop, review, and maintain SOPs for compounding, labeling, packaging, dispensing.
- Ensure adherence to USP <795>/<797>/<800>, VPP, PCAB in veterinary compounding.
- Review compounding logs, worksheets, and beyond-use dating for accuracy.
- Develop, execute and analyze QA metrics; report trends in monthly QMS meetings.
🎯 Requirements
- Bachelor's degree in pharmaceutical sciences, chemistry, biology, or related field (CPhT a plus)
- 1-3 years experience with a registered quality system in pharma manufacturing; GMP/regulatory audits preferred
- Strong Microsoft Office skills (Word, Excel, Outlook) and ability to learn new software
- Strong verbal and written communication; experience with trainings, docs, audits
- Ability to read and interpret complex regulations and develop pragmatic compliance solutions
- Team player who can take direction, show initiative, and multi-task; loves pets
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