Eurofins BPT-Columbia is seeking a Scientist II to join the Investigations team within our Biochemistry department. This role focuses on leading and supporting laboratory investigations in a regulated cGMP environment.
The successful candidate will partner cross-functionally to identify root causes, drive corrective and preventive actions (CAPAs), and ensure timely resolution of quality and laboratory investigations. This position requires a strong technical understanding of analytical testing, excellent problem-solving skills, and the ability to manage multiple priorities in a fast-paced environment.
Key Responsibilities
- Conduct and support laboratory investigations in compliance with cGMP and GLP requirements.
- Perform root cause analyses using tools such as Fishbone Diagrams and 5 Whys.
- Lead and document deviations, investigations, and CAPAs through completion.
- Collaborate with Quality, Operations, Analytical Development, and other departments to resolve issues within established timelines.
- Review data and documentation to ensure accuracy, quality, and regulatory compliance.
- Assess analytical results generated using techniques such as HPLC, CE-SDS, icIEF, ELISA, and cell-based assays.
- Maintain clear, thorough, and compliant documentation.
- Manage multiple investigations and projects simultaneously while meeting deadlines.
The ideal candidate would possess:
- Have practical knowledge of laboratory instrumentation (HPLC, CE-SDS, icIEF, ELISA, cell-based assays, etc.)
- Experience with a LIMS system desirable.
- Understanding of internal processes for investigational work.
- Ability to assess root cause using fishbone or 5 why’s.
- Ability to drive CAPAs and Investigations to completion on tight timelines by working across multiple departments.
- Attention to detail.
- Ability to work on multiple on-going projects.
Minimum Qualifications:
- Bachelor’s degree in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas.
- 1-3 years of experience working in a cGMP compliant lab
The position is full-time, Monday-Friday, 8am-4:30pm, with overtime as needed. Candidates who live within a commutable distance from Columbia, MO 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 holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.