Technical Compliance Associate

Stark Pharma Solutions Inc; Burlington (MA); Vor Ort; USD 70.000 - 95.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP knowledge

Quality systems

Technical writing

Investigation skills

Documentation

Cross-functional collaboration

Jobbeschreibung

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Technical Compliance Associate

Location: Massachusetts

Duration: Long Term

Job Overview

We are seeking a Technical Compliance Associate to support GMP manufacturing and Quality activities in a regulated manufacturing environment. The role will focus on GMP investigations, deviations, NCRs, CAPAs, change controls, impact assessments, batch documentation, audits, and manufacturing-floor support.

Key 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.

Required 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.