The QC Laboratory Supervisor I is responsible for the organization, administration, and supervision of the Lab Analysts. The quality control laboratory supervisor is responsible for the proper complete oversight of the day-to-day operations. This is to include document handling and provides oversight for lab systems and complete documentation of laboratory reports. Responsible for all exception reports, change request (CR's), instrument calibration, instrument maintenance and product records handled in the area.
- Responsible for the management and oversight of Lab Analysts to include hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
- Responsible for the operation and functions of the laboratory group which includes Raw Materials, Finished Products, Projects, validation samples, MEC and stability samples.
- Evaluation of analytical data, and based upon knowledge and experience, determines the sample disposition of materials tested.
- Identifies aspects of the tests or results warranting further attention and implement corrective actions.
- Write/updates procedures for operation, calibration, and training of laboratory instrument as well as laboratory practices.
- Auditing and maintenance of all laboratory procedures. Ensure inventory of chemical laboratory reference standards and laboratory supplies.
- May schedule laboratory test to provide support to production manufacturing activity. Assists in the periodic inspection of laboratory facilities, to assure that they are operated and administered according to GMP.
- Assists analyst with the analytical/microbial, instrumentation and maintain and inventory of the controlled substance transfers, record schedule, and schedule 4.
- Coordinate validation test with validation Department. Maintains track and trend in functional area.
- Under the direction the Section Manager (as applicable), assists all the periodic inspection of laboratory facilities, to assure that they are operated and administered according to Good Manufacturing Practices and good Laboratory Practices.
- Assign schedule to analyst based on business needs.
- Maintain QC Laboratory metrics.
- BS in science (Chemistry, Microbiology, or Biology).
- 2-5 years of analytical laboratory experience is required.
- Previous experience in the pharmaceutical industry as a coordinator or supervisor is strongly preferred.
- Demonstrated skills to deal effectively with members of the department and the areas serviced by the laboratory.
- Problem-solving skills are required.
- Must be able to interpret impact of laboratory data for appropriate and effective actions.
- Must be able to identify problem areas requiring development, maintenance, production, engineering, accounting, or planning with assistance from more senior staff.
- Must also be able to identify, communicate, and follow-through to completion and assist in the development of necessary corrective action plans to resolve the problem with supervision. May also assist in the activities required for the investigation and resolution.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Job Type: Experienced