Pharmaceutical Change Control Specialist

Eurofins USA PSS Insourcing SolutionsWest Point, PA
Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services to ensure products are safe, authentic, and accurately labeled. The Eurofins network is a global leader in various testing sectors, including pharmaceutical product testing. This role involves providing analytical change management for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs, ensuring compliance with cGMPs, GLPs, regulations, and policies. The specialist will coordinate all analytical change activities and support key commitments to improve compliance, efficiency, and performance within Laboratory Operations.

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
  • 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
  • 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
  • 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
  • vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation
  • holidays
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