Quality Technician – cGMP Data Review (2nd Shift)
West Pharmaceutical Services · Cidra
Job description
About the role
West Pharmaceutical Services seeks a Quality Technician to independently review analytical data for internal and external customers and support post‑production quality activities such as batch release, sterilization and packaging approval. The position works the 2nd shift (Monday‑Friday, 2 PM‑10:30 PM) and requires knowledge of local and international GMP regulations.
Key responsibilities
- Perform cGMP data review of raw material and finished‑goods analytical results, including container‑closure integrity and particle analysis.
- Review electronic data, audit trails and laboratory work instructions to ensure data‑integrity compliance.
- Approve batch release documentation, Device History Files and Certificates of Compliance.
- Validate packaging specifications and graphics artwork.
- Initiate SAP transactions related to batch release and sterilization processes.
- Support periodic management reviews and respond to documentation queries.
Required profile
- High school diploma or GED; no minimum experience required, though 1+ year in a cGMP environment is preferred.
- Ability to work independently, maintain punctual attendance and follow safety rules.
- Physical ability to perform sedentary work with occasional lifting of up to 10 lb.
- Willingness to travel up to 5 % of the time (≈13 business days per year).
Required skills
- cGMP data‑review and data‑integrity knowledge.
- Proficiency with SAP, MS Office, Adobe, MasterControl, LIMS and LMS.
- Experience reviewing electronic audit trails and electronic records.
- Understanding of packaging specifications and graphics approval.
- Basic to moderate English reading and technical writing ability.
What we offer
- Generous paid time off with flexible vacation, personal and holiday leave.
- Performance‑based bonuses and employee recognition programs.
- Inclusive, collaborative culture that values diversity, equity and inclusion.
- Continuous learning opportunities, tuition assistance and leadership development.
- Global career opportunities across North America, Europe and Asia‑Pacific.
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Published 5 days ago
Expires 1 month from now
17 views · 0 interested
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West Pharmaceutical Services
Cidra