Deviation Management Specialist

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

Keywords:

GMP, Pharmaceutical, Quality Control, QC, Deviations Investigation, Deviation Management, Quality Assurance, Commercial, FDA, CAPAs, Risk Management, RMPs, Change Controls, Biotechnology, Technical Writer, SOPs, Standard Operating Procedures, Writing, Reviewing, Revising, Authoring, #LI-ONSITE #LI-DF1