Specialist QA (3176960)
Location: East of Puerto Rico (Open to Puerto Rico residents)
Work Arrangement: 100% Onsite
Shift: Monday to Friday, 8:00 AM – 5:00 PM
Duration: Approximately 3 years
Opportunities Available: 1
Summary
Our client, a leader in the biotechnology industry, is seeking a Specialist QA to perform quality assurance activities under minimal supervision. This role supports the organization’s Quality Assurance program with a focus on ensuring compliance, data integrity, and operational excellence.
Preferred Qualifications:
- Knowledge of Warehouse and Incoming QC operations
- Experience in quality oversight functions and Quality Systems (e.g., deviations, CAPAs, change controls, temperature alarms)
- Familiarity with data integrity concepts
Key Responsibilities:
- Review and approve product master plans (MPs)
- Approve process validation protocols and reports for manufacturing processes
- Serve as a Quality representative on incident triage teams
- 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 manage site quality program procedures
- Serve as designee for the QA Manager on the local Change Control Review Board (CCRB)
- Review Risk Assessments
- Support Automation activities
- 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 control records
- Provide lot disposition and authorize lots for shipment
Education and Experience Requirements:
- 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 and Skills:
- Strong project management skills
- Excellent organizational abilities to ensure follow-through and completion of assignments
- Ability to initiate and lead cross-functional teams
- Strong leadership, influencing, and negotiation skills
- Expertise in manufacturing, distribution, QA, QAL, validation, and process development processes
- Experience interacting with regulatory agencies
- Proficient in Microsoft Word, PowerPoint, Excel, and database applications
- Strong verbal and written communication, facilitation, and presentation skills
- Ability to work independently and interact effectively with all levels of the organization
- Advanced data trending and evaluation capabilities
- Ability to assess compliance issues effectively
If you are ready to grow your career in the biotechnology industry and make a meaningful impact, we invite you to apply through the job description link and submit your updated resume!
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