Quality Assurance Specialist

Job Title: Quality Assurance (QA) Specialist
Location:  Andover, MA
Hours/Schedule: Monday–Friday, First Shift (8 am to 5 pm)
Type: Contract

The Quality Assurance (QA) Specialist supports manufacturing operations by performing routine QA tasks, reviewing documentation, resolving quality issues, and maintaining compliance with regulatory standards. This role ensures that production processes and records meet current Good Manufacturing Practices (cGMP) and supports continuous improvement across quality systems.

• Perform hands-on QA activities including batch record, document, and investigation review.

• Support product disposition activities in accordance with quality standards.

• Conduct on-floor QA reviews of executed batch records and logbooks for compliance.

• Perform production area walkthroughs, including GMP and compliance inspections.

• Provide QA expertise and guidance to colleagues in manufacturing areas.

• Support quality operations by addressing planned and unplanned manufacturing deviations.

• Escalate quality issues to QA management promptly.

• Review and approve SOPs, campaign start-up forms, validation protocols, and reports.

• Identify and implement continuous improvement opportunities aligned with corporate standards.

• Maintain inspection readiness and support internal and external audits.

• Interface with regulatory agencies during inspections and audits.

• Communicate effectively between Operations and Quality to ensure compliance and efficiency.

• Experience in Quality Assurance within a cGMP-regulated manufacturing environment.

• Knowledge of batch record review, deviation management, and document control.

• Familiarity with regulatory requirements and quality systems.

• Ability to work in a fast-paced environment and manage multiple priorities.

• Physical ability to stand, walk, bend, and lift up to 20 lbs as required for on-floor activities.

• Ability to gown and enter cGMP manufacturing areas per procedural requirements.

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.