What are the responsibilities and job description for the Senior GMP Investigations Specialist – Deviations & CAPA position at JMD Technologies Inc.?
Title: Senior GMP Investigations Specialist – Deviations & CAPA
Location: Greater Boston Area, MA (100% Onsite)
Employment Type: Contract
Hours: 40 Hours a week - Mon-Fri (8:00 – 5:00)
Status: Accepting Candidates
About the Role
We are seeking an experienced GMP investigations professional to support manufacturing operations within a clinical-stage cell manufacturing environment. This role will own quality records from initiation through closure, drive cross-functional investigations, and ensure compliance with GMP standards while supporting critical manufacturing timelines.
Key Responsibilities
- Lead and author Deviation Investigations, impact assessments, and root cause analyses for manufacturing-related quality events.
- Own and manage CAPA, Change Control, Risk Assessment, and Effectiveness Check records within the eQMS.
- Triage manufacturing issues in real time and collaborate with SMEs to determine containment and corrective actions.
- Drive cross-functional investigation meetings and ensure timely closure of quality records.
- Support operational compliance initiatives and promote GMP best practices across manufacturing teams.
- Track quality metrics and assist with prioritization of manufacturing technical operations activities.
Qualifications
- Bachelor's degree in Engineering, Science, or a related discipline.
- 6 years of experience in pharmaceutical, biotech, or cell therapy manufacturing environments.
- Strong experience owning Deviation Investigations, CAPA, and Change Control records from start to finish.
- Proven experience conducting investigations and technical writing in a GMP-compliant environment.
- Experience supporting manufacturing operations on the production floor and collaborating with cross-functional teams.
- Experience gowning and working in Grade B manufacturing environments preferred.
Compensation (MA Pay Transparency):
- Estimated hourly range: $50–$56/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
Salary : $50 - $56