The successful candidate will manage and support external testing activities within the Quality Control group to ensure alignment with the company’s quality program.
A typical day may include, but is not limited to, the following:
- Organizing and scheduling external testing to support product release and stability testing under cGMP guidelines
- Managing external data review according to the production schedule and stability program
- Acting as the primary point of contact with contract laboratory facilities
- Evaluating and monitoring the performance of contract labs
- Coordinating investigations at contract laboratories to ensure thorough technical content and compliant documentation
- Collaborating with internal Subject Matter Experts (SMEs) and Quality Assurance teams
- Coordinating the issuance and approval of Quality Agreements with contract labs
- Drafting Master Service Agreements, as needed
- Participating in GMP audits of contract labs
- Coordinating and leading quarterly meetings between contract labs and QC management
- Identifying and resolving technical issues at contract laboratories in collaboration with QC management
- Leading and overseeing daily quality control metrics meetings
- Managing compliance items and metrics within the group
This Role Might Be For You If:
- You have current or prior experience working in a regulated environment
- You have a demonstrated ability to work independently or as part of a team
- You possess strong troubleshooting and problem-solving skills
To be considered for this opportunity, you should have a BS/BA in Chemistry, Biology, or a related field with 5+ years of experience in laboratory management and analytical testing, as well as previous supervisory or leadership experience. Relevant experience may be considered in lieu of educational requirements.
