QA Specialist 3445259
Title: Specialist QA 34622
Location: East of Puerto Rico (Open to Puerto Rico Residents)
Schedule: Non-Standard Shifts
Positions Available: 1
Period: Approximately 3 years
Summary
Our client is seeking a Specialist QA to perform a wide range of Quality Assurance duties with minimal supervision. The selected professional will provide expertise in quality systems, compliance, validation, investigations, and regulatory readiness, supporting manufacturing operations and driving continuous improvement across site programs.
Preferred Qualifications
- Bachelor’s degree in Sciences or Engineering
- Experience with MES, LIMS, Maximo, and Batch Record Review
Key Functions
- Review and approve product Master Plans (MPs)
- Approve process validation protocols and reports for manufacturing processes
- Participate in incident triage teams as a Quality representative
- Approve Environmental Characterization reports
- Release 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 designee for QA Manager on local CCRB
- Review risk assessments
- Support automation initiatives
- Support facilities and environmental programs
- Review and approve Work Orders
- Review and approve EMS/BMS alarms
- Approve non-conformance (NC) investigations and CAPA records
- Approve change controls
- Provide lot disposition and authorize lots for shipment
Education Requirements
- Doctorate in a related field; 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 ability to follow assignments through completion
- Proven ability to initiate and lead cross-functional teams
- Advanced leadership, influencing, and negotiation skills
- Deep knowledge in QA, validation, manufacturing, distribution, and process development
- Demonstrated ability to interact with regulatory agencies
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, databases, and spreadsheets)
- Strong written and verbal communication skills, including facilitation and presentations
- Ability to work independently and effectively interact at multiple organizational levels
- Advanced skills in data trending, evaluation, and compliance issue assessments
- Commitment to demonstrating leadership values and practices
📌 If you are looking for an exciting career opportunity where you can make a meaningful impact in the pharmaceutical/biotech industry, we invite you to apply inside the job description link with an updated resume.