Quality Engineering and Validation
Stark Pharma Solutions Inc · Boston, MA · 4 wk ago
EngineeringFull-time
Key Responsibilities
- Provide QA oversight and support for GMP manufacturing operations and capital projects.
- Support validation activities, change controls, risk assessments, GMP investigations, and CAPAs.
- Identify quality risks and ensure compliance with GMP processes and quality systems.
- Review calibration records, preventive maintenance, work orders, and laboratory instrument qualification activities.
- Review and approve equipment, facility, and utility trending programs.
- Support environmental monitoring, routine testing, and facility control programs.
- Collaborate with cross-functional teams to ensure quality compliance and timely issue resolution.
Required Qualifications
- Master's degree with 3-5 years of relevant experience, or Bachelor's degree in Engineering, Scientific, or related field with 8+ years of relevant experience.
- Experience providing QA support for GMP manufacturing operations and validation activities.
- Experience with aseptic processing, investigations, root cause analysis, and CAPA.
- Knowledge of GMP regulations, quality systems, and risk-based decision making.
- Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.
- Strong communication, collaboration, problem-solving, and organizational skills.
Pay
Commensurate with experience.
Schedule
Long Term
Benefits
N/A
Skills
N/A
Benefits
N/A