QA Specialist (Biotechnology Industry) 3291355

Job Title: Specialist QA (Biotechnology Industry)

Job ID: 3291355

Location: Juncos, PR (Open for residents of Puerto Rico)

Work Schedule: 100% Onsite | Third Shift 9:00 PM to 5:30 AM - Monday to Friday

Duration: Approximately 3 years

Open Positions: 1

Join Our Client in Making a Difference in the Biotechnology Industry

We are seeking a highly skilled and motivated Quality Assurance Specialist to support our client’s Quality Assurance (QA) program within the biotechnology sector. This position will be performed under minimal supervision and requires deep expertise in Quality Oversight and Supply Chain or Incoming Operations. The ideal candidate will bring a strong background in regulated environments and a commitment to quality excellence.

Key Responsibilities

• Review and approve product Master Production Records (MPs).
• Approve process validation protocols and manufacturing process reports.
• Participate in incident triage teams and request QA support when needed.
• Approve Environmental Characterization Reports.
• Authorize the release of sanitary utility systems.
• Approve planned incidents and represent QA in New Product Introduction (NPI) teams.
• Lead investigations and site audits.
• Own and maintain site Quality Program procedures.
• Act as designee for QA Manager on the local Change Control Review Board (CCRB).
• Review and assess Risk Assessments.
• Support Automation, Facilities, and Environmental programs.
• Review and approve Work Orders and EMS/BMS alarm records.
• Approve Non-Conformance (NC) investigations and Corrective and Preventive Actions (CAPAs).
• Approve Change Control records.
• Provide lot disposition and authorize product lots for shipment.

Preferred Qualifications

• Experience performing Quality Oversight in a regulated manufacturing environment.
• Background in supporting Supply Chain and Incoming Operations.

Education Requirements

• Doctorate degree; OR
• Master’s degree and 2 years of directly related experience; OR
• Bachelor’s degree and 4 years of directly related experience; OR
• Associate degree and 8 years of directly related experience; OR
• High School diploma / GED and 10 years of directly related experience.

Core Competencies and Skills

• Project management and strong organizational skills.
• Ability to independently manage assignments through completion.
• Proven leadership, influence, and negotiation skills.
• Strong knowledge of manufacturing, distribution, QA, validation, and process development.
• Experience interacting with regulatory agencies.
• Proficiency in Microsoft Office Suite and data analysis tools.
• Excellent written and verbal communication skills.
• Skilled in facilitating cross-functional team collaboration.
• Advanced competency in data trending, evaluation, and compliance issue assessment.
• Demonstrated alignment with professional values and leadership practices.

If you are passionate about quality, compliance, and continuous improvement—and ready to make a difference in the lives of patients—this is your opportunity. We invite you to apply via the job description link with your updated resume. We look forward to connecting with qualified candidates committed to excellence in the biotechnology industry!