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iso 9001 audits gmp glp sop📋 Description
- Lead daily QA operations in Rochester, NY.
- Develop and maintain SOPs, protocols, and QA docs per ISO/GMP.
- Review/approve cGMP docs, batch records, QC data, COAs, and validation reports.
- Initiate and monitor CAPAs, deviations, investigations, and QA compliance activities.
- QA support to cross-functional teams; mentor staff on regulatory requirements.
- Collaborate with stakeholders, prep for inspections, drive quality improvements.
🎯 Requirements
- Bachelor's in life sciences with 5+ years quality systems exp.
- Non-degreed candidates with 10+ years GLP/GMP exp considered.
- Thorough knowledge of GLP/GMP, ICH & FDA guidelines (US & EU).
- Familiarity with global cGMP and ISO regs for veterinary products a plus.
- Experience creating/reviewing SOPs, WIs, batch records, protocols.
- Audits including regulatory inspections; cross-functional skills; MS Office.
🎁 Benefits
- Equal employment opportunities for all applicants.
- Prohibits discrimination and harassment.
- Policy covers recruitment, promotion, termination, and more.
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