Job Description
Job Summary:
- Execute tasks associated with sample management, shipment of samples, and other lab support QC functions, while interacting cross-functionally with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Management (MM), and Corporate teams.
Responsibilities (include but are not limited to):
- Receive incoming samples, verify documentation, and log sample information into LIMS.
- Execute processes to support sample receipt and processing or aliquoting for release/stability testing and retains.
- Label, store, and organize samples according to established procedures and storage requirements.
- Coordinate sample transfers to internal and external testing labs.
- Perform routine cleaning, maintenance, and restocking of sample storage areas.
- Collaborate with MM, QA, and other QC functions—including Corporate QC—to support requirements around sampling, testing, and disposition.
- Manage and complete all shipping activities within QC functions.
- Complete routine review of records, such as sample chain of custody forms, processing logs, logbooks, and other documentation generated within QC Lab Support.
- Assist with deviation and investigation activities as needed.
- Provide updates during daily and weekly meetings.
- Participate in Lean Lab and other Operational Excellence initiatives.
- Comply with all safety, quality, and regulatory guidelines.
- Perform other duties as assigned.
Education and Experience:
- Bachelor’s Degree.
- AA Degree and 2+ years’ experience working in Quality Control or biopharma laboratories preferably in an FDA regulated laboratory.
- High School Degree and 3+ years’ experience working in Quality Control or biopharma laboratories preferably in an FDA regulated laboratory.
Knowledge, Skills and Abilities:
- Strong knowledge in applying GMP in QC lab.
- Exceptional attention to detail and ability to keep track of multiple ongoing projects.
- Proficient in Microsoft Office, Excel, Visio, and other related applications.
- Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment.
- Comfortable in a fast-paces small company environment and able to adjust workload based on changing priorities.
- Ability to be flexible with schedule, and work overtime as needed.