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Manager Shop Floor QA - Vaccine

Pearl River, New York

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

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"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

SUMMARY

This Quality position ensures Quality Compliance oversight with cGMP, Regulatory and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the floor presence.  Quality oversight involves, but is not limited to:  auditing of manufacturing areas for compliance, deviation support, documentation support, trending, risk assessments, adherence to the program as documented. The Manager of Shop Floor QA will perform real time review of batch records and  logbooks, QA oversight of deviations, assist in investigations, in raw material release, and monthly GEMBA walk throughs.  There is an expectation that the Shop Floor Professional spends the majority of their time on supporting the manufacturing operation from the quality perspective.

JOB RESPONSIBILITIES:

Quality Review of Shop Floor Documentation:

  • Perform real time reviews of manufacturing batch records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.
  • Be present on the floor during batch processing
  • Perform consistent review of logbooks on shop floor (Manufacturing, QC, Engineering and Facilities).
  • Review completed log books for completeness and accuracy once off the floor
  • Review chart recorder print out and log pages.  Including EM/Water data

Shop Floor Walk throughs

  • Perform monthly GEMBA walk through manufacturing, QC, Engineering (Facilities) areas as assigned by DD, Product Quality
  • Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.
  • Provide reports to area managers to address any issues
  • Ensure facility is “inspection ready” at all times.

Material Management:

  • Perform raw material release for all incoming materials

  • Perform monthly review on cell bank and virus bank inventory

QA oversight of deviations and change controls:

  • Initiate deviations as required

  • Provide guidance to resolve compliance issues and procedural errors in real time.

  • Investigate deviations, as assigned

  • Close minor deviations

  • Assist in change controls approval to proceed/closures

Additional functions assigned:

  • First responder to address any non-routine events on shop floor

  • Quality review/release of engineering work order and preventative maintenance

  • Perform special projects as assigned by Deputy Director Product Quality

  • Team member of assigned project team(s).  This includes, but is not limited to, review and approval of project related requirement documents.

  • Assist in audit – QA representation for tours as needed

CONTEXT OF JOB:

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. 

The activities must be performed with high a level of quality/attention to detail in order to ensure quality products and meeting the needs of all 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

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, preferably in Science or Life Sciences WITH

  • 3+ years 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 in a cGMP controlled/ pharmaceutical industry

Competencies / Skills:

  • The ability to understand complex data

  • Strong attention to detail

  • Experience in technical writing

  • Excellent communication/interpersonal skills

  • Excellent organizational and teamwork abilities

  • Thorough knowledge of the cGMPs.

PREFERRED QUALIFICATIONS:

  • An Advanced degree in Science AND 3+ years experience in a cGMP controlled pharmaceutical environment

  • Experience in decision making, leadership, auditing and deviation investigations.

  • Software 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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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