Quality Assurance Specialist - Drug Product
Summary
Contract QA specialist (5 months, extendable) providing quality oversight of drug product manufacturing, packaging, and inspection at a biotech site in Juncos, Puerto Rico — reviewing batch records and validation documents, approving change controls/CAPAs, and authorizing lot release. Requires GMP QA experience and bilingual English/Spanish.
Provide Quality oversight of drug product manufacturing, packaging and inspection operations at a leading biotechnology company in Juncos, Puerto Rico. You will work with minimal supervision and make the quality calls that keep product moving.
What you'll do
- Review and approve master production records, process validation protocols and reports.
- Approve change controls, nonconformances, investigations and CAPA records.
- Represent Quality on incident triage and new product introduction teams.
- Review risk assessments, work orders and EMS/BMS alarms.
- Provide lot disposition and authorize lots for shipment.
Requirements
- Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, or High School + 10) of directly related experience.
- GMP Quality Assurance experience approving change controls, deviations, CAPAs, protocols and procedures.
- Packaging and/or inspection operations experience preferred.
- Good Documentation Practices and electronic quality systems.
- Bilingual English/Spanish.
Benefits
- Contract: 5 months, with possible extension
- Shift: Administrative, Monday–Friday (40 hours/week)
- Start: Immediate
Skills
As published by workable · 5 questions
Basics
First name, Last name, Email, Headline, Phone, Address, Photo, Education, Experience, Summary, Resume
Short answers (1)
- What is your expected hourly pay rate (USD/hr)?
Pick from a list (4)
- Are you legally authorized to work in the United States?
- Can you work in the United States without needing visa sponsorship, now or in the future?
- Have you approved change controls and CAPAs in a GMP Quality Assurance role?
- Do you have packaging or inspection QA experience?