Specialist QA (Regulated Industry) 3542617
Job Title: Specialist QA (Regulated Industry) – 3542617
Location: Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: 100% Onsite – Administrative Shift
Duration: Approximately 11 Months
Open Positions: 1
Position Summary
ProQuality Network is seeking a Specialist QA (Regulated Industry) by contract with our client to support its Quality Assurance program within a regulated pharmaceutical manufacturing environment.
Under minimal supervision, the selected candidate will perform critical QA functions to ensure compliance with cGMP regulations, internal SOPs, and applicable FDA requirements. This role requires strong expertise in drug substance operations, validation oversight, quality systems, and cross-functional collaboration to maintain inspection readiness and product quality.
Preferred Qualifications
- Bachelor of Science degree (Biology, Chemistry, Physics, or related Life Science discipline).
- Experience in Quality Assurance – Drug Substance operations.
- Strong background in quality and compliance within FDA-regulated environments.
- Experience reviewing and approving validation protocols and reports for:
- Clean utilities
- Manufacturing processes
- Cleaning validation
- Equipment qualification
- Computerized systems validation (CSV)
- Change control records
- Deviations and investigations
- Experience in biological processes is highly desirable.
Responsibilities
- Review and approve Master Production Records (MPs) to ensure compliance with validated processes and regulatory requirements.
- Review and approve process validation protocols and reports for manufacturing operations.
- Serve as QA representative on the incident triage team.
- Review and approve Environmental Characterization reports.
- Approve release of sanitary utility systems in accordance with validated state requirements.
- Review and approve planned incidents and related documentation.
- Represent Quality Assurance on New Product Introduction (NPI) teams.
- Lead and document deviation investigations, ensuring appropriate root cause analysis and CAPA implementation.
- Lead and participate in site audits to maintain inspection readiness.
- Own and maintain site Quality Program procedures, ensuring alignment with regulatory expectations.
- Serve as QA Manager designee on the local Change Control Review Board (CCRB).
- Review and approve risk assessments to evaluate product and compliance impact.
- Support Automation activities, including review of computerized systems documentation when applicable.
- Provide oversight to facilities and environmental programs.
- Review and approve Work Orders impacting validated systems.
- Review and approve EMS/BMS alarms to ensure compliance and appropriate response documentation.
- Review and approve Non-Conformance (NC) investigations and CAPA records.
- Review and approve change control records to ensure compliance with regulatory commitments.
- Provide lot disposition and authorize product release for shipment.
Education & Experience 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 degree + 8 years of directly related experience; OR
- High School Diploma/GED + 10 years of directly related experience.
Competencies & Skills
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Proven ability to initiate and lead cross-functional teams.
- Demonstrated leadership, influencing, and negotiation capabilities.
- In-depth knowledge of manufacturing, distribution, QA, QAL, validation, and process development in regulated environments.
- Experience interacting with regulatory agencies during audits and inspections.
- Advanced data trending, analysis, and compliance evaluation skills.
- Proficiency in word processing, presentation, database, and spreadsheet applications.
- Strong written and verbal communication skills, including facilitation and presentation abilities.
- Ability to work independently while effectively collaborating with all organizational levels.
- Strong understanding of compliance risk assessment and mitigation strategies.
- Demonstrated alignment with our client’s values and leadership practices.
If you meet the qualifications and are interested in this opportunity, we encourage you to apply through the job description link with an updated resume for consideration.