Deviation Management Specialist
Durham, NC
Job Id:
139165
Job Category:
Job Location:
Durham, NC
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Jake Maehrer
Piper Companies is seeking a Deviation Management Specialist to fill an opportunity with a reputable Pharmaceutical company in Durham, NC.
Responsibilities for the Deviation Management Specialist
- Investigate deviations by assessing product impact, identifying root causes, and implementing corrective/preventative actions.
- Author and update GMP documentation, including SOPs, batch records, validation documents, and change controls.
- Write quality incident and deviation reports, ensuring thorough analysis and compliance.
- Collaborate with cross-functional teams to drive process improvements, resolve investigations, and maintain compliance.
Qualifications for the Deviation Management Specialist
- 2–4 years of experience in deviation management and investigations within biologics, vaccines, or sterile manufacturing.
- Proficient in Change Control processes and technical writing.
- Strong communication, leadership, and teamwork abilities.
- Skilled in managing projects and meeting deadlines.
Compensation for the Deviation Management Specialist
- Salary Range is Commensurate with Experience
- Long Term Contract (Possible Extension)
- Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
This job opens for applications on 3/31/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Deviation, Investigation, Change Control, CAPA, Root Cause, Batch Record, GMP, Good Manufacturing Practice, Validation, Biologics, Vaccines, Pharmaceutical, Quality Assurance,
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