Quality Engineering and Validation
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-06
Listing for:
Stark Pharma Solutions Inc
Full Time
position Listed on 2026-08-06
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
We are hiring talented professionals for our client.
Position:Quality Engineering and Validation
Location:Boston, MA
Duration:Long Term
Job OverviewWe are seeking a Quality Engineering and Validation professional to provide quality oversight and GMP compliance support for clinical and commercial drug product manufacturing operations. The ideal candidate will have experience supporting GMP manufacturing, validation activities, investigations, and quality systems within a regulated life sciences environment.
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.
- 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, View Linc, or similar quality management systems.
- Strong communication, collaboration, problem-solving, and organizational skills.
Sravani Dasari
Talent Acquisition Specialist
Vakula Tech Inc.
Email:
Piscataway, New Jersey 08854
Website:
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