GMP Compliance & Quality Investigations Specialist

Stark Pharma Solutions Inc; Burlington (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Stark Pharma Solutions Inc. in Massachusetts seeks a Technical Compliance Associate to support GMP manufacturing and Quality activities in a regulated environment, focusing on investigations, deviations, NCRs, CAPAs, change controls, and batch documentation.

You will partner with Manufacturing, Quality, and Engineering to resolve compliance issues on the floor and support audits, with a strong emphasis on documentation and GMP procedures.

Qualifications

• Experience supporting GMP manufacturing and Quality activities.
• Hands-on experience authoring GMP investigations.
• Experience with deviations, NCRs, CAPAs, and change controls.
• Experience performing quality and compliance impact assessments.
• Experience reviewing batch documentation and manufacturing records.
• Experience supporting audits in a regulated manufacturing environment.
• Strong understanding of GMP and Quality systems.
• Strong technical writing, investigation, and documentation skills.
• Strong problem-solving and analytical skills.
• Ability to work effectively with Manufacturing, Quality, and cross-functional teams.

Responsibilities

• Author and support GMP investigations related to manufacturing and quality events.
• Support and own change controls, including impact assessments and required documentation.
• Manage and track CAPA actions through completion.
• Investigate and document deviations and non-conformance reports (NCRs).
• Review and support batch manufacturing and quality documentation.
• Perform impact assessments related to quality and compliance activities.
• Support internal and external audits and provide required documentation.
• Provide Quality and compliance support on the manufacturing floor.
• Partner with Manufacturing, Quality, Engineering, and other cross-functional teams to resolve compliance issues.
• Identify opportunities for continuous improvement in GMP processes and documentation.
• Ensure activities are performed in accordance with applicable GMP procedures and quality standards.

Skills

GMP knowledge

Quality systems

Technical writing

Investigation skills

Documentation

Cross-functional collaboration

Job description

Stark Pharma Solutions Inc. in Massachusetts seeks a Technical Compliance Associate to support GMP manufacturing and Quality activities in a regulated environment, focusing on investigations, deviations, NCRs, CAPAs, change controls, and batch documentation.

You will partner with Manufacturing, Quality, and Engineering to resolve compliance issues on the floor and support audits, with a strong emphasis on documentation and GMP procedures.