Chemical Testing (R-CCT2)
Chemist 2 – Chemical Testing (R-CCT2)
Location: Rochester, Michigan
- Performs routine and non-routine quality control testing of raw materials, in process, residual, finished product, and stability testing within the framework of site policies, departmental procedures, and cGMP regulations.
- Participates in transfer of methods, validations, investigations, team projects, and special studies to accomplish company and departmental goals.
- Assists in special testing studies of an experimental, investigative, and problem solving nature. Records and reports data accurately and in compliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMPs.
- In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
- Establishes and Maintains Effective cross functional relationships.
- Completes testing with a high degree of efficiency, reliability, and accuracy.
- Maintains the Chemical Testing Laboratory. This may include but not limited to maintenance, calibration, and use of standard laboratory equipment such as HPLC, GC and FT-IR.
- Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.
- Analyzes samples per test procedures and ensures all lab work is performed in accordance with SOPs, accurately recording information and results. Notifies supervision of unusual results for evaluation.
- Actively assumes and demonstrates responsibility in learning practical laboratory skills, and a thorough knowledge of chemical theories, methodologies and procedures.
- Knowledgeable of company and departmental policies pertaining to current Good Manufacturing Practices, current Good Laboratory Practices, safety, health, security, and departmental operation. Complies with company and departmental regulations, policies and guidelines in performance of the job.
- Reviews completed reports for accuracy and documentation of procedures, equipment and reagents used in analytical testing.
- Recognizes trends, deviations, problems within scope of job and promptly reports them to laboratory management. Follows directions and demonstrates proper judgment when a deviation occurs.
- Assists in training of other laboratory analysts.
- Assists in writing, editing and revising test procedures and SOPS.
- Assists in the execution of protocols, method transfers and validation studies.
- Prepares and standardizes test solutions.
- Participates in inventory control. Maintains a neat and orderly workspace.
Bachelor’s Degree with a major in Chemistry, or related field and minimally 2 years of related experience; or an equivalent combination of education and experience/training. Prior experience in a pharmaceutical laboratory is highly desired.
Strong knowledge of inorganic and organic chemistry principles and analytical techniques. Knowledge of compendia as applicable, cGMP guidelines, FDA regulations; laboratory safety procedures, laboratory instrumentation, and MSDSs. Working knowledge of Windows based software such as Word, Excel, Access, and Outlook and knowledge of chromatography data processing software is highly desirable.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
MCP Pharmaceuticals LLC HR Department, Job Code SAS
870 Parkdale Road
Rochester, Michigan 48307
To apply for this position, please Apply Online
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