Unicon Pharma Inc
GMP Operational Quality Senior Specialist
Unicon Pharma Inc, Boston, Massachusetts, us, 02298
GMP Operational Quality Senior Specialist
Base pay range: $55.00/hr - $65.00/hr
Duration: 6 months with chance to extend
Shift: 1st shift Sun-Wed 7am-5:30pm
Hours: 40 hours/week
Start: ASAP (backfill for maternity leave beginning 1/2026)
Overview: We are seeking a GMP Operational Quality Senior Specialist to support clinical and commercial drug product operations. This role provides hands‑on QA oversight, batch disposition, and on‑the‑floor quality support within a fast‑paced pharma/biotech environment.
Key Responsibilities
Provide GMP quality oversight for manufacturing and QA operations
Review batch records, deviations, QC data, EM data, and support batch disposition
Review and approve manufacturing documentation, COAs, and product release
Support investigations, change controls, CAPAs, OOS/OOT events
Perform Quality on the Floor activities and compliance walkthroughs
Partner cross‑functionally with Manufacturing, QC, Engineering, and Materials
Support inspection readiness and continuous improvement initiatives
Required Experience
Pharma or biotech background with strong QA experience
Hands‑on experience with batch record review and GMP data review
Experience supporting GMP manufacturing operations and product release
Strong understanding of cGMPs; cell & gene therapy experience highly preferred
Experience with deviation management, investigations, and CAPA
Familiarity with systems such as TrackWise and/or Oracle preferred
Education
Bachelor’s degree with 5+ years of relevant experience or
Master’s degree with 3+ years of relevant experience
Seniority level Mid‑Senior level
Employment type Contract
Job function Consulting
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Duration: 6 months with chance to extend
Shift: 1st shift Sun-Wed 7am-5:30pm
Hours: 40 hours/week
Start: ASAP (backfill for maternity leave beginning 1/2026)
Overview: We are seeking a GMP Operational Quality Senior Specialist to support clinical and commercial drug product operations. This role provides hands‑on QA oversight, batch disposition, and on‑the‑floor quality support within a fast‑paced pharma/biotech environment.
Key Responsibilities
Provide GMP quality oversight for manufacturing and QA operations
Review batch records, deviations, QC data, EM data, and support batch disposition
Review and approve manufacturing documentation, COAs, and product release
Support investigations, change controls, CAPAs, OOS/OOT events
Perform Quality on the Floor activities and compliance walkthroughs
Partner cross‑functionally with Manufacturing, QC, Engineering, and Materials
Support inspection readiness and continuous improvement initiatives
Required Experience
Pharma or biotech background with strong QA experience
Hands‑on experience with batch record review and GMP data review
Experience supporting GMP manufacturing operations and product release
Strong understanding of cGMPs; cell & gene therapy experience highly preferred
Experience with deviation management, investigations, and CAPA
Familiarity with systems such as TrackWise and/or Oracle preferred
Education
Bachelor’s degree with 5+ years of relevant experience or
Master’s degree with 3+ years of relevant experience
Seniority level Mid‑Senior level
Employment type Contract
Job function Consulting
Referrals increase your chances of interviewing at Unicon Pharma Inc by 2x
Get notified about new Quality Specialist jobs in
Boston, MA .
#J-18808-Ljbffr