Quality Assurance Specialist - Drug Product NPI and Validation
BioPharma Consulting JAD Group
Job Description
Job Description
Provide Quality oversight for drug product operations at a leading biotechnology company in Juncos, Puerto Rico, with a focus on new product introductions, change control and validation. You will work with minimal supervision and make the quality calls that keep projects and product moving.
What you'll do
- Represent QA on new product introduction (NPI) teams and support FATs.
- Review and approve process validation protocols and reports, including PPQs.
- Approve change controls, planned incidents, nonconformance investigations and CAPA records; act as QA designee on the change control review board.
- Review and approve master production records, risk assessments, work orders and EMS/BMS alarms.
- Lead investigations and site audits and own site quality program procedures.
- Provide lot disposition and authorize lots for shipment.
Requirements
- Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
- GMP Quality Assurance experience with NPI, change control, validation and PPQs; FAT experience preferred.
- Strong knowledge of manufacturing, QA, validation and process development processes.
- Able to lead cross-functional teams and interact with regulatory agencies.
- Advanced data trending and strong written and oral communication.
- Bilingual English/Spanish preferred.
Benefits
- Contract: 4 months, with possible extension
- Shift: Administrative, Monday–Friday (40 hours/week)
Vacancy posted 15 days ago
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