Overview
On Site
Full Time
Skills
Quality Control
Quality Assurance
Documentation
Pharmaceutics
Manufacturing
Technical Writing
Microsoft Office
GMP
Regulatory Compliance
Management
Job Details
Piper Companies is currently seeking a Deviation Management Specialist based in Durham, NC for work at a leading pharmaceutical company. The Deviation Management Specialist will play an integral role in conducting manufacturing/QC deviation investigations, authoring investigations as well as resolutions
Responsibilities of the Deviation Management Specialist:
Lead Quality Control and manufacturing operation deviation investigations
Conduct interviews with QC and manufacturing personnel working alongside quality assurance (QA)
Author/revise GMP documentation in support of commercial release of vaccine products
Write, review, and revise other GMP documentation such as SOPs, batch records and work instructions
Qualifications of the Deviation Management Specialist:
1+ years of experince within pharmaceutical manufacturing
2+ years of deviation investigation experince
1+ years of technical writing experince
Proficient in Microsoft Office Suite
Familiarity with FDA and GMP compliance regulations
Compensation for the Deviation Management Specialist:
Compensation is commensurate with experience
Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO
Responsibilities of the Deviation Management Specialist:
Lead Quality Control and manufacturing operation deviation investigations
Conduct interviews with QC and manufacturing personnel working alongside quality assurance (QA)
Author/revise GMP documentation in support of commercial release of vaccine products
Write, review, and revise other GMP documentation such as SOPs, batch records and work instructions
Qualifications of the Deviation Management Specialist:
1+ years of experince within pharmaceutical manufacturing
2+ years of deviation investigation experince
1+ years of technical writing experince
Proficient in Microsoft Office Suite
Familiarity with FDA and GMP compliance regulations
Compensation for the Deviation Management Specialist:
Compensation is commensurate with experience
Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO
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