What are the responsibilities and job description for the Change Control Specialist position at Eurofins?
Company Description
Are you looking for an exciting opportunity, a rewarding, enriching, and fulfilling career, and the opportunity to grow to greater levels of success with a company that values you? Then look no further! Join Eurofins PSS: a world class company that is growing by leaps and bounds while making a difference to humanity.
At Eurofins PSS, you will gain experience working in state-of-the-art laboratories, and be a part of a team that is dedicated to testing, development, and advancement of life-saving drug products to make the world a healthier and happier place to live in. Our people are our chemistry and we need talented people like you now more than ever.
Job Description
The purpose of this role is to author technical documents to change current processes for drug development.
- Collect details from cross-functional departments to author change controls for components and raw materials
- Enter change controls into electronic system (QTS) and routing to departments for assessments
- Track and project manage the assessment completion
- Route change control for approval, track and manage approvals
- Track task completion associated with approved change control and work with owners to ensure tasks are completed by assigned due dates
- Enter new enrollment tasks into electronic system (QTS) and assign task owners
- Extend enrollment due dates when needed
- Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities
- Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department
Qualifications
- Bachelor's degree in a scientific or engineering discipline or similar, with a minimum of 1 year GMP experience
- Lab experience is beneficial, but not required.
- Experience with changing lab processes, SOP's, procedures, etc.
- Knowledge of pharmaceutical supply chain or QA experience preferred
- Strong computer skills; specifically Excel and SAP
- Able to work both independently and as a member of a cross-functional team in a fast-paced environment
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Valid driver’s license and personal transportation
Additional Information
- This is a non-lab based-role - all duties will take place in an office environment.
- Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
