Job Description
Job Description
Title: QA Specialist (3537638)
Work Arrangement: Hybrid / Remote
Shift: Administrative
Number of Positions: 1
Contract Period: Approximately 9 months
Location: Open to Puerto Rico residents
Position Summary
The QA Specialist will support our client’s Quality Assurance program by performing a broad range of quality-related activities under minimal supervision. This role requires strong knowledge of GMP environments, cross-functional collaboration, and the ability to independently manage quality processes that support manufacturing, validation, and compliance activities.
Preferred Qualifications
- Bachelor’s degree or higher in Science or Engineering.
- Experience with:
- New Product Introduction (NPI)
- Change Control
- Documentation review
- Validation and PPQ (Process Performance Qualification)
- FAT (Factory Acceptance Testing)
Key Responsibilities
- Review and approve Manufacturing Procedures (MPs).
- Review and approve process validation protocols and reports for manufacturing processes.
- Serve as Quality Assurance representative on incident triage teams.
- Review and approve Environmental Characterization reports.
- Support release activities for sanitary utility systems.
- Review and approve planned incidents.
- Represent Quality Assurance on New Product Introduction (NPI) teams.
- Lead deviation investigations and root cause analyses.
- Lead and support site audits.
- Own and maintain site Quality Program procedures.
- Act as QA Manager designee on the local Change Control Review Board (CCRB).
- Review and approve risk assessments.
- Support automation-related quality activities.
- Support facilities and environmental quality programs.
- Review and approve work orders.
- Review and approve EMS/BMS alarms.
- Review and approve nonconformance (NC) investigations and CAPA records.
- Review and approve change controls.
- Perform lot disposition and authorize product release for shipment.
Education Requirements
One of the following is required:
- Doctorate degree
- Master’s degree plus 2 years of directly related experience
- Bachelor’s degree plus 4 years of directly related experience
- Associate degree plus 8 years of directly related experience
- High School diploma or GED plus 10 years of directly related experience
Core Competencies & Skills
- Strong project management and organizational skills with the ability to follow assignments through completion.
- Proven ability to initiate and lead cross-functional teams.
- Advanced leadership, influencing, and negotiation skills.
- Strong technical knowledge within area of expertise.
- Ability to collaborate and coordinate with internal and external stakeholders.
- Extensive experience in manufacturing, distribution, QA, Quality Laboratories (QAL), validation, and process development.
- Ability to effectively interact with regulatory agencies.
- Strong proficiency in word processing, presentations, databases, and spreadsheets.
- Excellent written and verbal communication, facilitation, and presentation skills.
- Ability to work independently and interact effectively at all organizational levels.
- Advanced skills in data trending, analysis, and evaluation.
- Strong ability to identify and assess compliance risks.
- Demonstrated alignment with our Client Values and Leadership Practices.
Interested Candidates
Qualified candidates are encouraged to apply directly through the job description link and submit an updated resume for consideration.
We look forward to connecting with you.