What are the responsibilities and job description for the Quality Assurance Specialist position at GForce Life Sciences?
GForce is seeking an experienced, Quality Associate consultant to join our growing pharmaceutical client.
This consultant will provide guidance to internal and External Service Provider (ESP) project teams for the GMP-related documentation and inquiries within assigned products and projects. Ensures timely review and approval of batch records documentation and associated quality records. Collaborates with Affiliates, ESP personnel, and internal project teams to ensure commercial products compliance with FDA GMP regulations, product-specific requirements, and applicable internal SOPs.
Responsibilities
- Manages the batch record review to support the product release GPQ activities of Commercial Products (API, drug product, and finished packaged product as assigned).
- Works collaboratively with Technical Operations and other Partners, Affiliates, and Subsidiaries as applicable in supporting the product release for commercial distribution.
- Writes and/or reviews various documents for Global Product Quality such as Protocols, Reports, SOPs, Risk Management, Quality Agreements, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls and other documentation as assigned.
- Works with Affiliates and Technical Operations to establish Specifications, Bill of Materials, and Master Batch records for commercial products.
- Works collaboratively with ESPs for the review of process changes and improvements, investigations, and root cause analysis of process deviations, corrections, corrective actions, out-of-trends, and OOS as applicable.
- Using Track Wise Digital (TWD) populates and submits for review Quality Events (QEs), Change Controls, Batches Records as assigned.
- Collaborates with cross functional team and prepares the Annual Quality Product Review for commercial products.
- Assists in the preparation, execution, report, and follow-up of internal and external audits.
- Reviews analytical documentation including stability reports, retention reports, OOS, and other related documentation as required.
- Ensures quality agreements are established for assigned suppliers per the clients Policies and Procedures.
Requirements and Preferences:
- Bachelor’s degree in Engineering, Chemistry, Biology, or related Science
- Minimum of five (5) years of combined and/or pharmaceutical manufacturing, QA, or QC assurance roles supporting commercial product and development project activities.
- 2-3 years of QA experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
- Knowledge of the GMP requirements for batch review and release of Commercial Product and/or Drug Development API or Bulk Drug Product.
- Knowledge in FDA 21 CFR 211 and 210
- Experience with TrackWise System (preferred) or any other Quality Management System (QMS) for handling deviations, change controls, complaints, CAPA, investigations etc.
Term & Start:
- 12 month contract, potential to extend
- Benefits (medical, dental, vision, 401k)
- Paid holidays
