Sanofi Group Lead QA Tech - Vaccine in Pearl River, New York
The Lead QA Tech will support four core activities.The Lead QA Tech will perform real-time review ofbatch records and logbooks, QA lead deviations and assist in the investigation, Raw Material release, and monthly GEMBA walk-throughs. There is an expectation that the Lead QA Tech will spend the majority of their time on the floor supporting operations from a quality perspective.
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 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
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 real time monthly review of logbooks on shop floor (Manufacturing, QC, Engineering and Facilities).
Review completed log books for completeness and accuracy once off the floor
Shop Floor Walk-throughs
Perform monthly GEMBA walk through manufacturing, QC, Engineering (Facilities) areas as assigned by Dep Director PQ.
Provide monthly walk through write ups to the area managers to address any issues
Ensure facility is “inspection ready” at all times
Review chart recorder print out and log pages on a weekly basis.
Review EM/Water data
Perform raw material release for all incoming materials.
Perform monthly review on cell bank and virus bank inventory
Lead deviations and change controls
Initiate deviations as required
Investigate deviations, as assigned.
Close minor deviations
Assist in change controls approval to proceed/closures
Additional functions assigned
Perform special projects as assigned by Deputy Director-Shop Floor 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
- Minimum Bachelor degree ( preferably in Science or Life Sciences ) AND experience 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 experience in a cGMP controlled pharmaceutical environment
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.
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.