Overview As a Deviations & Investigations Scientist in the Chemistry team in Columbia, MO, you drive quality and compliance in a GMP environment. You lead investigations of deviations and quality events, perform root-cause analyses, and develop CAPAs to protect data integrity. You collaborate with lab operations, QA, and technical teams to resolve issues and support stability and batch release programs. Your work enables continuous improvement and adherence to regulatory expectations. This role offers meaningful impact in ensuring safe, compliant testing services.
Compensation / Benefits- Comprehensive medical coverage
- Dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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
Key requirements- 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
- 1-3 years of experience in a cGMP compliant lab
- Authorization to work in the US indefinitely without restriction or sponsorship
- strong written and verbal communication
- attention to detail
- organization and time management
- HPLC
- GC
- LIMS
