Specialist QA 3539244
Title: Specialist QA (3539244) – Regulated Industry
Location: Puerto Rico (Open to local residents)
Work Schedule: 100% Onsite – Administrative Shift
Duration: Approximately 6 Months
Positions Available: 1
Position Summary
ProQuality Network is seeking a Specialist QA to support our client’s Quality Assurance program within a highly regulated manufacturing environment. This is a contract opportunity supporting critical QA operations onsite.
The selected professional will execute and lead quality assurance activities under minimal supervision, ensuring compliance with FDA regulations, global quality standards, and internal procedures. The role requires strong experience in validation, change management, investigations, NPI, and cross-functional collaboration within pharmaceutical or biotechnology operations.
Preferred Qualifications
- Education in Life Sciences, Engineering, or a related technical discipline
- Experience with NPI, Change Control, FATs, Validation, and PPQ activities
- Background in FDA-regulated pharmaceutical or biotechnology environments
Key Responsibilities
- Review and approve Manufacturing Procedures (MPs).
- Review and approve process validation protocols and reports for manufacturing processes (IQ/OQ/PQ/PPQ).
- Serve as QA representative on Incident Triage Teams.
- Review and approve Environmental Characterization Reports.
- Approve and release sanitary utility systems.
- Review and approve planned incidents, non-conformances, and CAPA records.
- Represent QA on New Product Introduction (NPI) teams.
- Lead quality investigations, ensuring timely root cause analysis and corrective actions.
- Lead and support site audits and inspection readiness activities.
- Own and maintain site quality program procedures.
- Act as designee for QA Manager on the local Change Control Review Board (CCRB).
- Review and approve risk assessments and change control documentation.
- Support automation, facilities, and environmental programs from a QA oversight perspective.
- Review and approve work orders and EMS/BMS alarms.
- Provide lot disposition decisions and authorize product release for shipment.
Education Requirements
- Doctorate degree OR
- Master’s degree + 2 years of directly related experience OR
- Bachelor’s degree + 4 years of directly related experience OR
- Associate’s degree + 8 years of directly related experience OR
- High School Diploma/GED + 10 years of directly related experience
Core Competencies & Skills
- Strong project management and organizational skills, with the ability to drive assignments to completion
- Demonstrated ability to initiate and lead cross-functional teams
- Advanced skills in influencing, negotiation, and stakeholder management
- Strong knowledge of manufacturing processes, QA/QAL systems, validation, and process development
- Experience interacting with regulatory agencies and supporting inspections
- Advanced data trending, analysis, and risk evaluation capabilities
- Strong technical writing and documentation review skills
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and database systems
- Strong written and verbal communication skills
- Ability to work independently while collaborating effectively across multiple organizational levels
- Ability to assess and resolve complex compliance issues
If you meet the qualifications and are interested in this contract opportunity, we invite you to apply directly through the job description link with an updated resume for consideration.