Deviation Management Specialist

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

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