Professional Product Quality Batch Release - Vaccine

1st or 2nd shift position based on the business needs
The Product Quality (PQ) Batch Release Professional supports two core activities: Lot Release Protocols & Batch Record Review/Disposition. The PQ Batch Release Professional will be involved in the creation of methods to improve the efficiency of the Lot Release Protocol & Batch Record Review/Disposition processes. Other activities may include completion of ESUM, revision of documents, and designation of work by PQ BR Deputy Director.
Lot Release Protocols

• Obtain data to populate Lot Release Protocols (LRPs)
• Populate LRP according to procedure and submit the completed populated LRP to Batch Release management for review.
• Use current master controlled lot release protocols (LRP) to populate both QO approved test and manufacturing data for submission to regulatory agencies (CBER, BRDD, and International Countries).
• Ensure right first time population and accuracy of data including the highest quality laboratory data so the data is searchable under electronic LRP.
• Maintain master controlled documents through the EDMS system and create new templates as required.
• Publish the LRP for electronic submission to regulatory agencies.
• Ensure LRP submission meets cycle time requirements for product releases, and SAP confirmation for completion of activity.
• Act as designee to Batch Release management for LRP reviews.
• Work with Regulatory Affairs as the technical expert for the preparation and review of US and International Lot Release protocols.

Batch Record Review/ Disposition

• Schedule, prioritize and prepare batches for disposition as applicable for all manufacturing areas at Swiftwater and distribution of final product to market.
• Assemble the batch jackets, which are viewed during Health Authority inspections.
• Prepare the Certificate of Analysis, which lists all acceptance criteria and test results related to a batch of product.
• Performs cGMP review of media/reagent/product batch records and release of media/reagents/products.
• Verifies Mfg/Expiry dates in PDRs.
• Prepares and/or approves commodity verification sheets for vaccine formulation, required for manufacturing to bulk.
• Performs batch record certification, required for manufacturing to execute the batch.
• Follow up and work effectively with colleagues throughout the organization to ensure timely disposition of product.

Compliance and Performance

• Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety.
• Record GMP data on documents (LRP and Batch Record dossiers) right first time with >95% accuracy, completeness and compliance.
• Execute on time changes to master documents such as LRP aligned with revised product specifications to ensure changes are completed on time.
• Complete SAP transactions in real time as activities are performed.
• Meet cycle time commitments for population of LRPs per departmental agreements/commitments, support Right First Time projects.
• Perform all other tasks as assigned by Manager.
• Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

QUALIFICATIONS:

• Bachelor's Degree
• Preferred Qualification: Experience in GMP working environment

The position requires intense concentration and visual examination of GMP documents. Data not entered right first time causes delay in product disposition to the market, potential loss of sales, potential recall, and/or customer complaints. Certification of working documents, review and release of media reagent and review of lot release protocols are measured for productivity and quality. The activities must be performed with high level of quality to ensure quality and meet the needs of our customers. The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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