Manager, Shop Floor QA
Pearl River, New York
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Manager, Shop Floor QA
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, and weekly 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.
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 logbooks for completeness and accuracy once off the floor
Review chart recorder print out and log pages. Including EM/Water data
Shop Floor Walkthroughs
Perform weekly GEMBA walk through manufacturing, QC, Engineering (Facilities) areas as assigned by DD, Quality Assurance
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.
QA oversight of deviations, CAPAs, ERs and change controls
Provide direction for deviation initiations as required
Provide guidance to resolve compliance issues and procedural errors in real time.
Assist Investigators on deviation strategy, as assigned
Close minor and deviations
Manage CAPA creations, implementation reviews and ERs
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 manufacturing areas
Perform special projects as assigned by Deputy Director Quality Assurance
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 THE 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.
Minimum High School diploma with 10 years’ experience working in a cGMP regulated company, preferably in the bio-pharmaceutical industry.
A Bachelor degree, preferably in Science or Life Sciences, with 3+ years in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment.
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.
An Advanced degree in Science AND 3+ years Quality experience in a cGMP controlled pharmaceutical environment
Experience in Geode, Word, Excel preferred.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.
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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