Lead QA Specialist — GMP, CAPA & Compliance
Pinnaql, Inc.
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Job summary
Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Specialist QA to uphold quality systems in pharmaceutical, biotech, and related industries in Puerto Rico.
The role covers reviewing MPs, approving validation protocols, leading investigations, and coordinating with manufacturing and engineering teams. The ideal candidate will have advanced degrees with substantial GMP/QA experience, strong regulatory interactions, bilingual English/Spanish abilities, and proven
Qualifications
- Doctorate or Masters with directly related experience, or Bachelor with related experience, or Associates with extensive related experience, or High school/GED with extensive related experience.
Responsibilities
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Release of sanitary utility systems.
- Approve planned incidents.
- Lead investigations.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Skills
Education
Job description
Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Specialist QA to uphold quality systems in pharmaceutical, biotech, and related industries in Puerto Rico.
The role covers reviewing MPs, approving validation protocols, leading investigations, and coordinating with manufacturing and engineering teams. The ideal candidate will have advanced degrees with substantial GMP/QA experience, strong regulatory interactions, bilingual English/Spanish abilities, and proven
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