Senior Quality Analyst
Job Type: Full-time / Contract
Work Location: Onsite
Experience Level: 3–5 years
Job Summary
We are seeking a Senior Quality Analyst to support manufacturing operations and ensure compliance with quality systems, GMP requirements, and applicable regulations. This role will support investigations, product impact assessments, risk management, documentation review, quality events, and manufacturing activities.
Schedule & Work Environment
- 100% onsite position supporting a 24/7 manufacturing operation.
- Candidates must be available to work any shift, including weekends and holidays.
- Rotating schedule: 4 days per week, 10-hour shifts, with approximately 2-month rotations across 1st, 2nd, and 3rd shifts.
- Overtime may be required based on business needs.
- Must be comfortable working in a manufacturing environment and responding to changing priorities.
Key Responsibilities
- Maintain and support the effectiveness of the Quality Management System.
- Support manufacturing operations with quality events, investigations, impact assessments, and documentation discrepancies.
- Review and approve investigations, risk assessments, and product/process impact assessments.
- Place product on QA hold when required based on quality or product impact.
- Review and approve SOPs, change controls, risk management documents, and other quality documentation.
- Support validation activities and participate in Validation Review Board meetings.
- Review calibration, out-of-tolerance, and preventive maintenance records.
- Ensure manufacturing practices comply with approved procedures, GMP, company policies, and regulatory requirements.
- Support internal and external audits and collaborate with Quality and Manufacturing teams.
- Provide quality support for new product introduction and develop risk assessments for manufacturing activities.
- Promote EHS compliance and continuous improvement.
Qualifications
- Bachelor's degree in Biotechnology, Biology, Chemistry, Engineering, or a related scientific field.
- Master's degree in Science is preferred.
- 3–5+ years of experience in the pharmaceutical, biotechnology, or related regulated industry.
- Experience with Quality, GMP, compliance, investigations, risk management, and manufacturing operations.
- Knowledge of regulations and standards applicable to biological/pharmaceutical products.
- Strong written and verbal communication skills in English and Spanish.
- Ability to manage multiple priorities and work effectively in a fast-paced manufacturing environment.
- Strong attention to detail, problem-solving, and decision-making skills.
Pay: $24.00 - $34.00 per hour
Benefits:
Education:
Experience:
- pharma or biotech or medical device industry: 3 years (Preferred)
- Investigations/: 3 years (Preferred)
- Deviations: 3 years (Preferred)
- risk management/risk assessments: 3 years (Preferred)
- reviewing/approving validation documents: 3 years (Preferred)
- change control: 3 years (Preferred)
Ability to Commute:
- Barceloneta, PR 00617 (Preferred)
Work Location: In person
