Looking for Successful Leaders
The role of the Quality Control Chemist is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical chemistry assays of raw materials, finished formulations, stability samples, client-based & company-based pharmaceutical projects, method development and/or transfers, and cleaning study qualifications.
- Perform In-Process, Finished Product and Stability testing using HPLC, Dissolution and wet chemistry techniques.
- Analyze raw materials using USP/NF or in-house developed testing methods.
- Perform timely instrument qualification as they come due.
- Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP and company policies and procedures.
- Provide training and assistance to other group members.
- Investigate and troubleshoot analytical problems, write OOS reports, Deviation reports, and CAPA reports
- Work on multiple projects in a fast-paced environment.
- Maintain good cGMP practices by following detailed SOP’s, maintaining training, laboratory notebooks and good documentation practices.
- Operate and maintain all analytical instrumentation and equipment as per established procedures.
- Perform semi-complex adjustments to lab equipment and instruments, calibration and preventative maintenance of equipment, including completing appropriate documentation.
- Maintain a safe and clean working environment by performing routine area housekeeping and reporting unsafe conditions.
Level 1: Office Environment and Production Environment
This job operates in a professional office environment as well as the Production and Warehouse environment. This role routinely uses standard office equipment such as computers, phone, photocopiers, filing cabinets and fax machines, as well as commanding the understanding and sometimes operation of complex machinery used in the manufacturing of solid oral dose drug products.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands or arms. Must be able to lift 10 pounds.
This is a full-time position.
Required Education and Experience
- Bachelor’s degree in Chemistry and a minimum of 2-4 year’s laboratory experience in the pharmaceutical industry in Quality Control.
- Must have experience in the QC testing of pharmaceutical/biologic products in a GMP environment.
- Experience working closely with manufacturing and development teams.
- Computer proficiency and excellent MS Office skills.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced, small company environment with ability to adjust workload based upon changing priorities.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with our without notice.