What are the responsibilities and job description for the Change Control Specialist position at Eurofins USA PSS Insourcing Solutions?
Job Description
Job Description
Company Description
The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up.
We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in Agroscience CRO services.
It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you’re looking for a rewarding career, a place to call home, apply with us today!
Job Description
- Collecting details from cross-functional departments to author change controls for components and raw materials
- Entering change controls into electronic system (QTS) and routing to departments for assessments
- Tracking and project managing the assessment completion
- Routing the change control for approvals
- Tracking and project managing approvals
- Tracking task completion associated with approved change control and working with owners to ensure tasks are completed by assigned due dates
- Entering new enrollment tasks into electronic system (QTS) and assigning task owners
- Extending 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
The purpose of this role is to author technical documents in an effort to change current processes for drug development.
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
LI-EB1
Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
