Quality Assurance Specialist

Insight Global is seeking a QA Associate to work for one of our largest pharmaceutical manufacturing companies in the Andover, MA area. This person will demonstrate sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks. This role supports Operations including batch record review, document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching.

Project work, as needed, will also be expected.

• Provides ongoing site-based Operations support for both start up and ongoing product manufacturing.
• Competently reviews simple batch records and associated simple deviations and simple analytical investigations. (Cal OOTs, RAAC, CIS and Events)
• Able to resolve less challenging quality issues and make simple batch disposition decisions with guidance and coaching.
• Able to review and approve documents in PDOCS with quality mindset.
• Uses established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching.
• Makes decisions that require knowledge of quality systems.
• Represents QA on various Teams with direction from management.
• Exercises judgment in resolving simple quality issues.
• Able to review executed batch documentation for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.
• Manages own workload with oversight by manager/peer.
• Represents their quality records with Board of Health inspectors, with support of management, as needed.
• Maintains inspection readiness and supports internal/external audits as needed.
• Supports QA on the floor rotation .
• Manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Review and approve Manufacturing records to ensure that the information and documentation conforms to company policy and cGMP's.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.

Must Haves:

• 1+ years of experience with batch record review and QA documentation