Professional Product Quality Batch Release

Job description

Function/Department : Quality Operations/Product Quality Batch Release

Reporting to (Title of manager(s): Deputy Director, Product Quality Batch Release

Solid Line : Deputy Director, Product Quality Batch Release

Matrix (Dotted Line): N/A

Location :  Protein Sciences, Pearl River, NY

Summary of purpose/major responsibilities

The Product Quality (PQ) Batch Release Professional supports three core activities.  The PQ Batch Release Professional  will perform data entry/quality review of Lot Release Protocols, Batch Record Review/Disposition process, Shop floor activities including real time review of BR/logbooks, QA oversight of deviations, and monthly walk throughs.

Key accountabilities

Quality Review of Batch Records

·  Perform Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.
·  Complete all required transactions associated with the batch record review process.

Disposition of Batches and Raw Materials

·  Review Specification Checklist, to verify all required testing has been performed and all testing meets requirements prior to batch disposition.
·  Create Certificate of Analysis
·  Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.
·  Complete all required transactions associated with the batch disposition process.
·  Release incoming raw materials

Quality Data Entry / Review of Lot Release Protocol (LRP)

·  Data Entry / Review LRP for completeness and accuracy prior to submission PQ Deputy Director for final review and submission.
·  Ensure LRP creation meets cycle time requirements for product release.

Shop Floor Activities (QC, MFG, ENG and Facilities)

·  Review completed log books for completeness accuracy
·  Perform monthly walk through manufacturing, QC, Engineering (Facilities) areas as assigned by Dep Director PQ.
·  QA oversight of deviations – initiate deviations on the floor and assist in the investigation process.

Compliance and Performance

·  Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.
·  Investigate deviations, as assigned.
·  Perform special projects as assigned by PQ Deputy Director.
·  Team member of assigned project team(s).  This includes, but is not limited to, review and approval of project related requirement documents, Change controls, forms, protocols, reports, user and functional specifications, etc.
·  Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

Context of the job/major challenges

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.

Dimensions/Scope ​

Breadth of responsibility (global/regional/country/site): Protein  Sciences, Pearl River, NY

Key dimensions : headcount (direct and indirect) budget, doses, Capex… - Key indicators on which the job holder will be evaluated (WHAT in 9box): The job holder will be evaluated on Safety, Cost, Quality, Supply, and Site Project support as established in site and department objectives.

Freedom to act, level of autonomy : The incumbent is expected to work independently with a level of autonomy and authority for decision making within the defined scope of the job that is necessary to drive process improvements, ensure lot release plans, and ongoing compliance to requirements in the dossier and current GMPs.

Basic Qualifications: ​

·  Minimum Bachelor degree required (preferably in Science or Life Sciences)
·  Experience in a cGMP controlled/ pharmaceutical industry (preferably in a regulated Quality environment) OR
·  An advanced degree in Science/Life Sciences if <3 years relevant experience.

Key technical competencies and soft skills :

·  Ability to understand complex data,
·  Attention to detail, technical writing, excellent communication/interpersonal skills, excellent organizational and teamwork abilities,
·  Thorough knowledge of the cGMPs.
·  Experience in Geode, Word, Excel preferred.

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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