JT619 - SPECIALIST QA
Quality Consulting Group•Juncos, PR
•Onsite
About The Position
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Requirements
- Possess a BS in Science, Engineering, Physics, Biology, Chemistry or related fields.
- Experienced working in biopharmaveutical industry, quality organization supporting deviations, validation reports, qualifications, investigations.
- 5 years of experienced in a highly regulated environment.
- Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc.
- Experience in biological processes
- Strong knowledge and hands-on experience with Aseptic manufacturing processes
- Change Control Experience
- Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation
- Manufacturing and laboratory experience required
- Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions
- Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities
Responsibilities
- Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
- Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
- Approve process validation protocols and reports, including PPQs and cleaning validation documentation
- Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
- Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
- Approve Environmental Characterization and environmental monitoring reports
- Release and maintain compliance of sanitary utility systems
- Represent Quality Assurance on New Product Introduction (NPI) teams
- Lead and document investigations, root cause analyses, and CAPA development
- Lead and support site audits, including internal, external, and regulatory inspections
- Own, maintain, and continuously improve site quality program procedures
- Serve as QA Manager designee on the local Change Control Review Board (CCCCR)
- Review and approve risk assessments and mitigation strategies
- Support automation systems, including review of validation and change documentation
- Support facilities, utilities, and environmental compliance programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
