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QA Principal Compliance Specialist – Operations
| Company | Sanofi |
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| Location | Framingham, MA, USA |
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| Salary | $74250 – $107250 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- Master’s Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, Associate’s Degree and 8 years of experience, or a High School Diploma and 10 years of experience in a Quality and /or other CGMP related field.
- 2 years of experience in a Quality role.
- Working experience in external agency regulatory audits (FDA, EMA, etc.).
- Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.
- Prior experience leading teams or projects.
- Knowledge in external agency regulations (FDA, EMA, etc.)
- Strong computer, verbal and written communication skills.
- Experience in quality systems.
- Experience in leading cross functional teams.
- Experience with Trackwise or equivalent system.
- Proficient in Microsoft Office.
Responsibilities
- Provide Gemba Support
- Function as shift lead including developing junior employees
- Perform batch record review
- Perform review of column packing and qualification records
- Review and sign-off on manufacturing supervisor notes
- Review and approve CRs related to EBRs (as applicable)
- Function as SME on challenges related to production requiring a quality input
- Non-conforming material discard
- Perform log book review
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
- Issue action notices and conduct affiliated provisional release
- Conduct log book audits against compliance requirements
- Review CV related documentation against specification
- Perform Bulk Raw Material Release
- Perform media / buffer and intermediate release
- Perform release of Cell Banks for forward processing (as applicable)
- Support cross-functional internal audit activities and conduct walkthrough inspections
- Function as department lead for internal audits
- Function as CAPA owner
- Execute containment activities
- Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
- Function as document owner as needed
- Maintain a high level of personal compliance to the required standards
- Partner with manufacturing and support operations to ensure a culture of continuous compliance
- May provide training to new employees
- Review of Quality Critical Alarms and NRSR
- Initiate and investigate and QA review deviations
- Provide off-hour support for batch record and log book issuance
- Represent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA)
- Function as back-up for QA Manager
- Other activities as assigned
Preferred Qualifications
- Bachelor’s degree in a scientific field with 6+ years of experience in a Quality and / or cGMP environment.
- 4+ year’s experience in a Quality Assurance role.
- Experience in bio-pharmaceutical industry.
- Capable of analyzing trends and metrics that lead to improvement.
- Strong technical writing skills.
- Effective time management, attention to detail, organizational skills, teamwork and collaboration.
- Significant capability in problem solving methodology.
- Experience working in an environment of operational excellence.
- Experience training and developing employees.
- Experience participating in external agency inspections.
- Knowledge of regulatory enforcement trends.
- Ability to work independently.
