Quality Assurance Specialist

Work Location: Hartford County, Connecticut

Summary:

The QA Specialist is responsible for supporting and maintaining quality documentation, ensuring compliance with regulatory standards, and providing quality assurance support across operational areas. This role involves reviewing batch records, supporting audits, managing quality systems, and participating in compliance projects to ensure product quality and regulatory adherence.

Responsibilities:

• Develop, revise, and manage quality documentation, including procedures, material specifications, and certificates for final products.
• Review executed batch records and provide QA support to QC and Operations teams for timely product release.
• Lead and support compliance projects, ensuring adherence to regulatory and internal quality standards.
• Assist in internal and external audits, manage supplier quality agreements, and monitor supplier performance.
• Oversee quality management of computerized systems, interpreting relevant regulations for compliance.
• Handle and approve stability reports, quality incidents, investigations, deviations, and related documentation.
• Support validation of operational processes, analytical methods, and equipment in accordance with GMP requirements.
• Participate in complaint investigations, prepare periodic quality reports, and ensure staff training compliance with GMP standards.

Qualifications:

• BS in Biology, Biochemistry, Chemistry, or related technical/physical science.
• Minimum 2 years of experience in the pharmaceutical regulated industry within Quality Assurance, compliance, manufacturing quality, or regulatory affairs.
• At least 2 years of direct or indirect leadership experience in a group setting within a GMP environment.
• Working knowledge of CGMP practices (21 CFR Parts 210, 211) and ability to interpret 21 CFR part 211 and 11 for computerized systems.
• Experience with systems such as SAP and Document Control Systems.
• Strong interpersonal and cross-functional collaboration skills.
• Ability to work independently, lead task groups, and solve complex technical and people-related problems.
• Result-focused, able to handle conflicts, and drive for mutually agreed decisions.
• Cultural awareness and understanding of diverse behaviors.
• Fluent in English.
• Qualified as a visual inspector for AQL inspections and able to work in ISO 5/6 cleanroom environments.

Published Category: Quality & Validation