Specialist QA 3089937
Specialist QA (Biotechnology Industry) – Job ID: 3089937
Location: East Puerto Rico (Open to Puerto Rico Residents)
Work Type: 100% Onsite | Administrative Shift
Duration: Approximately 8 Months
Position Available: 1
Summary
We are seeking a highly skilled Specialist QA to support our client’s Quality Assurance program with minimal supervision. The selected candidate will be responsible for ensuring compliance with quality standards, regulatory requirements, and manufacturing processes.
Preferred Qualifications:
✅ Experience with change control, product disposition, process validation, cleaning validation, and quality aspects of manufacturing processes.
Key Responsibilities:
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Act as QA representative on incident triage teams.
- Approve Environmental Characterization reports.
- Oversee the release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on New Product Introduction (NPI) teams.
- Lead investigations and site audits.
- Own and maintain site quality program procedures.
- Serve as a designee for the QA Manager on the local Change Control Review Board (CCRB).
- Review and assess risks in manufacturing and quality processes.
- Support automation activities, facilities, and environmental programs.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve non-conformance (NC) investigations and CAPA records.
- Oversee and approve change controls.
- Provide lot disposition and authorize shipments.
Education & 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.
Key Competencies & Skills:
✔ Project management and organizational skills.
✔ Ability to initiate and lead cross-functional teams.
✔ Strong leadership, negotiation, and influencing skills.
✔ Extensive knowledge of manufacturing, distribution, QA, validation, and process development.
✔ Experience interacting with regulatory agencies.
✔ Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).
✔ Excellent written and verbal communication, facilitation, and presentation skills.
✔ Ability to work independently and collaborate effectively with various levels.
✔ Advanced data trending and evaluation skills.
✔ Ability to assess and ensure compliance with industry regulations.
If you meet the qualifications and are interested in this opportunity, we encourage you to apply by submitting your updated resume through the link provided.
We look forward to reviewing your application! 🎯