QA. Specialist
Title: Specialist QA (Biotechnology Industry)
Location: East of Puerto Rico (100% onsite, non-standard shift) Open for Puerto Rico residents
Positions Available: 4
Duration: Approximately one-year contract with ProQuality Network
Summary
We are seeking a Quality Assurance Specialist to support our client’s Quality Assurance program with minimal supervision. The ideal candidate will have a strong background in manufacturing process audits, batch record review, and familiarity with DAI processes, PASx/MES applications, MAXIMO, SAP, and LIMS. This role requires availability for non-standard shifts, including nights and weekends.
Key Responsibilities
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as the Quality representative in incident triage teams.
- Approve Environmental Characterization reports.
- Oversee sanitary utility system releases.
- Approve planned incidents.
- Represent Quality Assurance (QA) on New Product Introduction (NPI) teams.
- Lead investigations and site audits.
- Manage site quality program procedures.
- Act as a designee for the QA Manager on the local Change Control Review Board (CCRB).
- Review Risk Assessments.
- Support automation, facilities, and environmental programs.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve Non-Conformance (NC) investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize shipments.
Qualifications
Education & Experience:
- 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.
Competencies & Skills
- Strong project management and organizational skills.
- Ability to lead cross-functional teams and drive initiatives.
- Expertise in manufacturing, distribution, QA, QAL, validation, and process development.
- Strong problem-solving, decision-making, and compliance evaluation skills.
- Excellent communication (written & oral), facilitation, and presentation skills.
- Advanced data trending, evaluation, and regulatory interaction experience.
- Proficiency in word processing, spreadsheets, presentations, and databases.
- Strong ability to work independently and collaborate across various levels.
This is an excellent opportunity to contribute to a dynamic Quality Assurance team within the biotechnology industry. If you meet the qualifications and are interested, apply now by submitting your updated resume using the link provided in the job description.