R&D Senior Quality and Compliance Analyst
4 semanas atrás
We are seeking a highly skilled R&D Senior Quality and Compliance Analyst to join our team at Kenvue. As a key member of our R&D organization, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities
Ensure attendance to GxP requirements for Pilot Plant and R&D Labs.
Revise and approve protocols and reports related to test methods development and validations, equipment management, and other required activities.
Develop and revise standard operating procedures and specific GMP/GLP documentation within R&D Compliance processes and R&D processes.
Proactively investigate and develop improvements to existing processes or develop new processes.
Conduct batch record reviews and issue product certificates of conformance.
Lead compliance projects to promote continuous improvement within R&D specific processes for pilot plant and/or R&D laboratories.
Interact with and provide guidance to R&D professionals on GxP regulatory requirements.
Interpret regulations to provide risk analysis guidance and make decisions about R&D GxP activities accurately.
Lead and/or support the internal and external Q&C audit program, regulatory inspections, and Inspection Readiness Program.
Lead investigations, CAPA, and change controls.
Requirements
Bachelor's Degree in Pharmacy, Chemistry, Engineering, or related science is required. Pharmacy is preferred.
Proven experience of at least 4-6 years in a regulated industry. Pharmaceutical Industry is preferred.
Experience in quality control and/or analytical development laboratory.
Working knowledge of CAPA, Change Control, and General Quality Systems process.
Knowledge of regulatory environment related to laboratory and method development and validation.
Advanced knowledge of Microsoft Office (Excel, PowerPoint, Word).
What We Offer
Competitive Total Rewards Package.
Paid Company Holidays, Paid Vacation, Volunteer Time & More.
Learning & Development Opportunities.
Employee Resource Groups.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
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