Specialist QA 3316003 (Biotechnology Industry)
Job Title: Specialist QA (3316003) – Biotechnology Industry
Location: East Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: 100% Onsite | Administrative Shift
Duration: Approximately 1 Year
Open Positions: 1
Position Summary
We are currently seeking a highly motivated and experienced Quality Assurance (QA) Specialist to join our client's team in the biotechnology industry. This role will support Amgen’s Quality Assurance program with minimal supervision and will involve oversight of critical quality activities related to manufacturing, validation, compliance, and regulatory documentation.
Key Responsibilities
- Review and approve Master Production Records (MPs)
- Approve process validation protocols and final reports for manufacturing processes
- Serve as the QA representative during incident triage processes
- Approve Environmental Characterization reports
- Release sanitary utility systems for use
- Review and approve planned incidents
- Represent QA in New Product Introduction (NPI) teams
- Lead quality-related investigations
- Serve as QA lead during site audits
- Own and maintain site quality program procedures
- Act as QA Manager designee in the local Change Control Review Board (CCRB)
- Review and assess risk evaluations
- Support automation systems and related quality activities
- Participate in facility and environmental program compliance
- Review and approve work orders, EMS/BMS alarms
- Approve non-conformance investigations and associated CAPA records
- Review and approve change control requests
- Provide final product lot disposition and authorize release for shipment
Preferred Qualifications
- Bachelor’s degree in Science or Engineering
- Experience in a pharmaceutical or biotechnology manufacturing environment
- Fluent in Spanish and English (spoken and written)
- Strong expertise in:
Commissioning and qualification of equipment, systems, and facilities
Auditing protocols and execution of qualification activities
Reviewing and approving technical documents (URS, design specs, technical reports)
Quality assurance methodologies, tools, and terminology
- Familiarity with Veeva and CDOCS document management systems
Education Requirements
Candidates must meet one of the following:
- Doctorate 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 and time management capabilities
- Organizational excellence and attention to detail
- Ability to lead and influence cross-functional teams
- Demonstrated knowledge in manufacturing, QA, validation, and distribution processes
- Experience interacting with regulatory agencies
- Proficiency in MS Office applications (Word, Excel, PowerPoint)
- Strong written and verbal communication skills
- Capable of working independently and collaborating across teams
- Expertise in data trending, evaluation, and compliance issue resolution
- Commitment to company values and leadership practices
If you meet the qualifications and are interested in contributing to a high-performing team in a dynamic, regulated environment, we invite you to apply with your most updated resume inside the following link.
We look forward to reviewing your application!