- Location: Pottstown, PA
- Type: Direct Hire
- Job #35753
Our client, who specializes in quality control testing and multi-assay validation is searching for a Quality Control Manager to join their team. This individual will be responsible for reviewing test results, validation of assays, and leadership of a team.
- Validation of established assays to ensure characterization and identification of proteins and antibodies.
- Review test results and approve lot releases of finished products based on established criteria.
- Optimize procedures to increase throughput of testing for all assays.
- Engage in method optimization, troubleshooting and qualification/validation as required.
- Make and implement recommendations for optimization and troubleshooting of testing assays.
- Validation, documentation and inventory management of raw material (antisera), reagents and other materials used in QC testing.
- Ensure QC team’s compliance with appropriate SOPs and internal documentation requests.
- Develop new SOPs and policies as needed for quality control activities.
- Train QC team members on immunoassays including IEP, ELISA, SDS-PAGE and Western Blot.
- Train other scientists on methods used by the QC group.
- Participate in project team activities and/or departmental initiatives and other responsibilities assigned by Manager.
- BA/BS in biochemistry, pharmacology, molecular biology, immunology, or related field. Advanced degree preferred.
- A minimum of 5 years’ hands on experience in performing antibody-based assays such as IEP, Western Blotting, immunofluorescence, ELISA, etc.
- Excellent experimental design and data analysis skills.
- Know-how in data handling and management using standard software (e.g. Excel) is required.
- Knowledge of QSR/cGMP guidelines or other good documentation processes is a plus.
- Excellent communication and organizational skills, ability to interact and communicate effectively within and across teams and willingness to learn