Deviations & Investigations Scientist
Eurofins Agroscience Services North Carolina
Eurofins BPT-Columbia is seeking a Deviations & Investigations Scientist to join our Chemistry team in Columbia Missouri. This partially remote position is responsible for supporting laboratory investigations deviation management stability studies and batch release activities within a GMP-regulated environment.
The Deviations & Investigations Scientist serves as a key contributor to quality and compliance initiatives by leading and documenting investigations associated with laboratory deviations out-of-specification (OOS) results out-of-trend (OOT) findings atypical results and other quality events. This role partners closely with laboratory operations Quality Assurance and technical teams to identify root causes assess impact implement corrective and preventive actions (CAPAs) and maintain compliance with regulatory expectations.
This intermediate-level position combines scientific expertise with technical writing data analysis and quality systems knowledge. The successful candidate will independently manage investigations review analytical data support stability and batch release programs and contribute to continuous improvement efforts while ensuring data integrity and adherence to GMP requirements.
Key Responsibilities
- Lead and author laboratory investigations related to deviations OOS OOT atypical results and quality events.
- Perform root cause analyses and support development and implementation of CAPAs.
- Review analytical data and laboratory documentation to support investigation conclusions.
- Support stability testing and batch release activities through data review and quality assessments.
- Collaborate with laboratory quality and operational teams to resolve technical and compliance issues.
- Ensure investigations are completed accurately thoroughly and within established timelines.
- Maintain compliance with GMP GLP regulatory client and internal quality requirements.
- Utilize LIMS and quality systems to manage documentation and maintain records.
- Prepare technical reports investigation summaries and supporting quality documentation.
- Identify quality trends and contribute to process improvements and operational excellence initiatives.
Qualifications :
The ideal candidate would possess:
- Experience with GLP and/or GMP and hands-on experience with HPLC and/or GC desirable.
- Experience with LIMS system desirable.
- Familiarity and/or experience in a laboratory setting is required.
- Good organizational skills; ability to follow direction and good communication skills are required.
- Ability to work on multiple on-going projects.
Minimum Qualifications:
- Bachelors 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
- Authorization to work in the US indefinitely without restriction or sponsorship
Additional Information :
Position is full-time position Monday - Friday 8:00am - 4:30pm. Candidates currently living within a commutable distance of 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.
Remote Work :
No
Employment Type :
Full-time
$114.6k - $234.6k
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