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 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.
• 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

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