Specialist QA 2959532
Job Title: Specialist QA
Location: Juncos, PR (Open to U.S. citizens residing in Puerto Rico)
Shift: 9:00 PM to 5:30 AM, with flexibility to work non-standard shifts
Positions Available: 1
Contract Duration: Approximately 3 years
Employment Type: Contract with ProQuality Network
Summary
We are seeking a Specialist QA to represent ProQuality Network at our client’s facility in Juncos, PR. The selected candidate will perform various Quality Assurance duties to support the client’s QA program under minimal supervision.
Educational & Software Requirements
Candidates must meet one of the following qualifications:
- 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.
Preferred Background:
- Degree in Sciences is highly preferred.
- Knowledge in Warehouse and Incoming QC operations, quality oversight, quality records (e.g., deviations, CAPAs, change controls), and data integrity concepts is strongly desirable.
Key Responsibilities
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as Quality representative on incident triage teams.
- Approve Environmental Characterization reports and sanitary utility system releases.
- Approve planned incidents and participate in New Product Introduction (NPI) teams.
- Lead investigations, site audits, and cross-functional teams.
- Own site quality program procedures and act as a designee for the QA Manager on local CCRB.
- Review Risk Assessments and support automation activities.
- Oversee facilities and environmental programs.
- Review and approve Work Orders, EMS/BMS alarms, NC investigations, and CAPA records.
- Approve change controls and provide lot disposition for shipment authorization.
Competencies & Skills
- Strong project management and organizational skills.
- Ability to lead, influence, negotiate, and interact with cross-functional teams.
- Advanced knowledge of manufacturing, distribution, QA, QAL, validation, and process development processes.
- Excellent communication (written and oral), facilitation, and presentation skills.
- Proficiency in data trending, evaluation, and compliance issue analysis.
- Experience with regulatory agency interactions.
- Skilled in word processing, database management, and spreadsheet applications.
- Strong ability to work independently and collaborate across various levels.
Why Join ProQuality Network?
This opportunity offers a chance to contribute to impactful projects while representing ProQuality Network at one of the leading organizations in the pharmaceutical industry.
If you meet the qualifications and are ready for an exciting challenge, we’d love to hear from you! Please apply inside the job description with an updated resume.