Our client is a leading global CDMO that offers services related to drug substance, drug product, and drug product lifecycle. They offer their clients and customers end-to-end collaboration for the design, production, and R&D of small molecule treatments at every stage of the lifecycle. At every stage of the lifecycle, they provide end-to-end collaboration to their clients and customers for the design, manufacture, and R&D of small molecule medicines. The QC Manager is responsible for the day-to-day operations of the isolated intermediates and finished goods testing subgroup of QC and will report to the Director of Process Support and Quality Control, oversees the subgroup's immediate daily operations.
The QC supervisor will oversee the day-to-day operations of the Quality Control lab, including the scheduling of manpower resources, the evaluation and approval of product releases, staff training, and testing assistance. This role will need interaction with all parts of the production facility.
Responsibilities include, but are not limited to:
- Overseeing and organizing daily QC testing priorities, including personnel and equipment scheduling and lab productivity evaluations
- Participating on teams as the Quality Control liaison as needed As appropriate Direct management of laboratory personnel, including degreed chemists and extra laboratory support personnel. As appropriate and requested, providing comments and assessments.
- Approval or rejection of raw materials, in-process items, and final goods based on corporate and customer standards
- Troubleshooting problems with laboratory instruments
- As needed, train laboratory personnel. As needed, monitor the training plan and matrix to ensure compliance and employee competency.
- Assisting with laboratory testing using HPLC, GC, Data Station, FT-IR, UV-vis, AA, and computer analysis.
- Assisting with the administration of essential laboratory programs such as the stability program, decreased testing, Environmental Services, retained samples, and so forth.
All personnel are obliged to follow DEA, EPA, FDA, and cGMP standards as they pertain to the Business's operations, as well as all company safety rules and procedures. All employees are required to arrive to work on time and on schedule. Other responsibilities related to the department's objective that are not clearly included in this section may be allocated.
- BS in Chemistry
- 3 or more years of experience within quality control or a development laboratory. Experience in pharmaceuticals highly preferred and beneficial
- cGMP expertise necessary
- Laboratory supervisory experience needed
- Laboratory experience supporting manufacturing processes very desirable
- Working knowledge of general lab equipment as specified
- The ability to problem solve and prioritize daily/weekly demands in order to reach shipment deadlines is required.
- Proficiency in a Windows-based environment, including word processing, spreadsheet, and database products, is required.