QUALITY CONTROL ANALYST – OPERATIONS (TEMP/CONTRACT)
Partner Therapeutics is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.
The Quality Control Operations group, within the QC Department, is responsible for operational support of the lab-based testing related to the manufacturing and release of Leukine. These activities include Release/CoA, LIMS, Stability, equipment commissioning, APR/Trending, DP CMO relationship management, training coordination, and other QC operational programs for the entire QC department.
This Individual will report to the QC Operations Supervisor and will contribute to the general operation, data output & management for the QC testing labs. The QC Analyst works independently under general supervision and will participate with the QC team to meet group goals.
- Routine review of assay documentation.
- Responsible for sample management such as shipping and receiving test requests/samples. Routinely perform inventory counts and dispose of completed samples. Pull stability samples according to schedule.
- Compile DP and BDS lot files for disposition for both release and stability.
- Support equipment installation and management processes.
- Data entry, verification, and trending.
- Use the LIMS system for sample management, new/revised protocols, specifications, and testing requirements.
- Author and collaborate on SOPs.
- Coordinate training records for QC staff.
- Ability to work with multiple departments.
- Perform other additional job-related duties, as required.
- Bachelor’s Degree in Life Science discipline and 2 years’ experience in lab environment, preferably regulated (ex. cGMP)
- Scientific / technical knowledge with experience in laboratory setting
- Proficient in MS office and data management systems
- Experience troubleshooting and investigating assay and equipment issues