Quality Compliance Official, Shop Floor QA

Job description

Context of the job:

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: deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation following non-routine events.

This Quality position ensures Quality Compliance oversight for auditing, deviation support, technical advice, real-time coaching, support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, gowning scenario decision making, documentation support, trending analysis, risk assessment, adherence to site programs, area releases, and other non-routine events. 

Objectives:

Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.
Increase quality culture in the manufacturing areas.
First responder to address any non-routine events on shop floor.
Provide guidance to resolve compliance issues and procedural errors in real time.
Perform periodic shop floor audits/walk-throughs.
Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.

Key Responsibilities

Product Pathway Assessment
Tagging area/equipment out of service
Releasing area/equipment back in service
Area/Line Clearances
Review Documentation – Logbooks, SRNs, Daily Releases, Batch Records, etc.
Deviations Support – Risk Assessments and Closures
Aseptic behavior review and coaching
Aseptic Process Simulations / Interventions Observations
Audits, walk-throughs, GEMBAs, technical coaching

Dimensions/Scope

This position is a 2nd shift, Tues-Sat, and subject to move based on business justification.

Requirements

Education/experience

Bachelor’s Degree or Higher in a science-based or related field.

A minimum 1-3+ years’ experience, in a Quality Role, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs and regulatory requirements. 

Preferred experience in decision making, leadership, auditing, and deviation investigations.

Certifications

N/A

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.