Pharmaceutical Change Control Specialist
About The Position
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. This role will provide analytical change management for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs, ensuring compliance in the laboratory in accordance with cGMPs, GLPs, regulation, and policies/procedures. The specialist will coordinate all analytical change activities in the laboratories and support key commitments for analytical change within Laboratory Operations aimed at elevating compliance, efficiency, assay robustness, and performance of the laboratories.
Requirements
- BS or MS in the life sciences
- At least 5 years change control/project management experience
- Previous GMP experience necessary
- Must be legally eligible to work in the United States indefinitely without restriction or sponsorship
- Proven ability to manage multiple projects/tasks simultaneously
- Working knowledge of general laboratory skills and techniques
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Excellent communication skills, oral and written
- Strong organization and attention to detail
- Ability to learn new techniques, keep accurate GMP records, follow instructions, and comply with company policies
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Nice To Haves
- Project Management, Change Execution Management and Team Leadership experience in a Quality function
- Biochemistry/Chemistry/Virology lab experience preferable
Responsibilities
- Providing analytical change management for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs
- Ensuring compliance in the laboratory in accordance with cGMPs, GLPs, regulation, and policies/procedures
- Coordination of all analytical change activities in the laboratories
- Support key commitments for analytical change within Laboratory Operations aimed at elevating compliance, efficiency, assay robustness, and performance of the laboratories
Benefits
- comprehensive medical coverage
- dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
