Specialist QA (Biotechnology Industry)
Quality Assurance Specialist (3013386)
📍 Location: East Puerto Rico (Open to Puerto Rico residents)
💼 Work Setup: Hybrid/Virtual
📅 Duration: One Year
👥 Positions Available: 2
Job Summary
We are seeking a Quality Assurance Specialist to support our client’s Quality Assurance program with minimal supervision. The ideal candidate will have experience in Quality Systems management and Validation, along with familiarity with PASx/MES applications, MAXIMO, SAP, LIMS, QMTS, and Veeva. Availability to work on weekends and holidays as needed is required. Experience with our client’s processes is preferred.
Key Responsibilities
✅ Quality & Compliance Oversight:
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as Quality representative in incident triage teams.
- Approve Environmental Characterization reports.
- Oversee the release of sanitary utility systems.
- Approve planned incidents and change controls.
✅ Investigation & Auditing:
- Lead and manage non-conformance (NC) investigations and CAPA records.
- Represent Quality Assurance in New Product Introduction (NPI) teams.
- Conduct and lead site audits.
- Serve as designee for QA Manager on the local Change Control Review Board (CCRB).
✅ Risk Management & Process Improvement:
- Review and approve Risk Assessments.
- Support Automation activities and ensure compliance with industry standards.
- Support facilities and environmental programs.
- Review and approve Work Orders and EMS/BMS alarms.
- Own and manage site quality program procedures.
- Provide lot disposition approval and shipment authorization.
Education & Experience Requirements
Candidates must meet one of the following educational and experience requirements:
- Doctorate degree OR
- Master’s degree with 3+ years of directly related experience OR
- Bachelor’s degree with 5+ years of directly related experience OR
- Associate’s degree with 10+ years of directly related experience OR
- High school diploma/GED with 12+ years of directly related experience
Required Skills & Competencies
✔ Project management and organizational skills – ability to follow assignments through to completion.
✔ Cross-functional leadership – initiate and lead teams across departments.
✔ Strong communication and negotiation skills – ability to influence and collaborate at multiple levels.
✔ Expertise in manufacturing and distribution processes, QA, QAL, validation, and process development.
✔ Regulatory compliance knowledge – ability to interact effectively with regulatory agencies.
✔ Technical proficiency – experience with word processing, database management, spreadsheets, and presentation tools.
✔ Advanced data trending and evaluation – ability to assess compliance risks and propose improvements.
✔ Ability to work independently and manage complex projects.
This is a great opportunity to join a team dedicated to quality and compliance in the pharmaceutical industry. If you meet the qualifications and are ready for this challenge, apply today inside the job description with your updated resume! 🚀