Supervisor, QC Raw Materials
This position provides oversight for cGMP testing for raw materials used in manufacturing processes. Position is responsible for day to day operations of laboratory and additionally responsible to provide technical input for methods.
- Trains and mentors staff, in performing routine testing and performing non-routine testing of raw materials in support of multiple manufacturing facilities in a cGMP environment.
- Reviews methods and procedures, to ensure compliance with corporate policies and procedures. Reviews data obtained for compliance to specifications and reports abnormalities.
- Coordinates prioritization and scheduling of all incoming samples to ensure on time delivery to customers. Works on continuous improvements for area to increase productivity and efficiencies.
- Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results.
- Collaborates with management and Learning and Development on appropriate course content for training programs.
- Maintains expertise in multiple test methods Represents area as SME in regulatory inspections.
- Performs and/or participates in investigations for out of specification results.
- Writes technical reports and reviews and revises standard operating procedures as needed.
- Performs data analysis and trending for method transfers and process investigations.
- Leads projects related to quality control programs as assigned Administers departmental program to assure proper calibration and maintenance of laboratory equipment and leads the investigation and troubleshooting of equipment, testing and process abnormalities.
- Coordinates interdepartmental activities, providing technical expertise to ensure that the programs are in compliance with current industry standards.
- Oversees outsourced analytical testing Performs as SME for the Warehouse Raw Material Sampling functions.
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred
- Minimum of 6 years of experience as in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory. Experience as people leader is preferred.
- Expertise with raw material test methods in accordance with USP, EP, JP, and ACS.
- Operational knowledge with the following analytical instruments, Karl Fisher Titrator, Polarimeter, Osmometer, UV-Vis Spectrometer, FTIR, Near IR, Gas Chromatography, UPLC, and HPLC.
- Previous experience with method transfer desired.
- Experience with LIMS and Smart lab computer applications a plus.
- Ability to lead a dynamic work force.
- Proficient in common computer software applications.
- Strong general laboratory and organizational skills, effective communication skills, both oral and written.