Senior QC Chemist
Brooksville, FL US
Title: Sr. QC Chemist
Location: Brooksville, FL
Salary: 90k an up depending on experience
Employment Type: Direct Hire
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
The QC chemistry department is responsible for the analytical cGMP testing of sterile products developed and manufactured. This includes coordinating and testing of raw materials, finished products and the stability program testing, testing of utility systems that support manufacturing, development and validation of analytical methods, HPLC assay development and qualification, monitor and maintain the laboratory in good quality, assist in the validation and periodic certification of the manufacturing facility, develop and execute equipment protocols, perform work in a safe, accurate and professional manner.
This position also performs the review and approval for work performed by others in QC lab and works closely with manufacturing to support operations and manufacturing processes.
- Use analytical equipment for testing such as pH meter, osmometer, viscometer, particle size analyzer, TOC analyzer, conductivity meter, UV/Vis spectrophotometer, HPLC, and GC.
- Perform testing of raw materials, utilities and product for release and stability. Testing is performed and reviewed in a timely manner with high accuracy and reliability.
- Peer review of laboratory notebooks for accuracy and compliance to the analytical method.
- Create and revise standard operating procedures for the chemistry laboratory; revisions may be related to procedural improvements, client requests and/or audit observations; create and revise protocols and procedures for new equipment and processes.
- Write, review, and revise raw material and finished product release and stability specifications; write, review, and revise stability protocols.
- Perform investigations; write and complete CAPAs, deviations and change controls; interact with other departments and or clients as needed.
- Maintain accurate inventory and tracking records of supplies and equipment; Write, revise, review, and execute IQ/OQ/PQ protocols on laboratory equipment; Troubleshoot and minor repairs to laboratory equipment; Ensure good housekeeping and maintains bench, laboratory, and supply rooms in a clean and orderly manner in accordance with cGMP s, EU and FDA requirements
- Coordination of the stability program including setup and scheduling stability pulls; includes coordination with chemistry, microbiology, and outside test labs to ensure testing and review is performed in a timely manner; includes coordination with quality assurance to ensure issuance of certificates of analysis in timely manner
- Perform qualifications and validations of analytical methods, including HPLC methods for identification, potency, and related substances evaluations. Assist in the development of HPLC methods.
- Develop, write, and revise methods for analytical procedures; develop, write, and revise procedures for use of laboratory equipment; Maintain and create other documentation as required
- Write, revise, and review technical reports
- Interact with other departments, including quality assurance and production, to ensure smooth overall workflow
- Coordinate with contract laboratories for outside testing
- Assist in the training of laboratory personnel
- Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards
- All other duties as assigned by management
- Bachelor s degree and minimum of 5 years related experience in quality control/CGLP/CGMP laboratory OR Master s degree and minimum of 3 years related experience in quality control/CGLP/CGMP laboratory OR equivalent combination of relevant education, experience and training