Pharmaceutical QA Associate Job at Insight Global, Andover, MA

ZFdDWGY4YmNjV1JIWVVjOGVjTURkZmpkRVE9PQ==
  • Insight Global
  • Andover, MA

Job Description

Our pharmaceutical client is looking for a QA Specialist to join their team. 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
  • 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.
  • 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 .
  • 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.
  • Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing operations.

M ust Haves:

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

Plusses:

  • experience with LIMS and SAP

Job Tags

Similar Jobs

DZ Corporation

Industrial Maintenance Electrician Job at DZ Corporation

 ...bending, and climbing for extended periods. Working in noisy, dusty, or hot environments. Would you like me to tailor this description for a specific industry (e.g., concrete, food processing, manufacturing)? Or add certifications like OSHA, forklift, or welding?... 

Lockheed Martin Corporation

Test Pilot C-130J-Level 5 Job at Lockheed Martin Corporation

At Lockheed Martin, we apply our passion for purposeful innovation to keep people safe and solve the world's most complex challenges. Pioneering Defense Technology: From aerospace to outer space to cyber space, you can innovate mission solutions alongside the best ...

Creative Cove Inc.

Copywriter Job at Creative Cove Inc.

Our Metrowest retail client is looking for a Copywriter with 3+ years' experience for a contract that's Temp to Hire and onsite 2-3 days a week in the Metrowest. The Copywriter will ideally have either retail or consumer goods experience, and a passion for storytelling...

AdaptHealth LLC

Warehouse Technician Job at AdaptHealth LLC

 ...maintenance, stocking and staging inventory, and inventory maintenance. The technician assists the supervisor or manager in pulling and loading equipment for delivery in addition to assembly of equipment when necessary, maintaining confidentiality and all other aspects of... 

White & Case LLP

Senior Advisor, Lateral Partner Recruitment Job at White & Case LLP

Position Summary Working as part of the Lateral Partner Recruiting team, reporting to the Director of Partner Recruiting in the US, the role holder has responsibility for providing administrative support to all aspects of the Firms lateral partner recruiting processes...