Description
Quality Control Chemist:Description:
1. Perform analytical testing on inactive and active ingredients, packaging components, and in-process, finished product and stability samples to ensure product is safe, effective, and meets established Eisai quality standards. Train/mentor additional QC staff on analytical testing as needed.
2. Review or prepare documentation of all laboratory work (i.e., test results, investigations, instrumentation/equipment preventative maintenance and calibration) in accordance with cGMP, cGLP, or standard operating procedures (SOP), as appropriate. Ensure all laboratory work is conducted in compliance with applicable safety and environmental regulations.
3. Evaluate laboratory results critically by comparing to established specifications, acceptance criteria, and historical trends. Recognize and record unexpected laboratory developments.
4. Use a wide variety of sophisticated equipment with responsibility for operation, maintenance, and daily calibration check (if appropriate).
5. Assist with drafting and/or revising formal documents (i.e., test protocols, summary reports), SOPs, and procedural guidelines when provided with the appropriate format.
Requirements:
- knowledge of cGMP/cGLP requirements
-M.S. or Bachelors degree chemistry with
-2+ years experience
-responsible for performing analytical testing and data review activities
-ability to prioritize, plan and schedule activities with multiple functional groups
-Knowledge of commonly used laboratory instrumentation and software
-Computer literacy
-Lifts and carries laboratory solvents/supplies up to 10-20 pounds
-Remains standing/on feet for extended durations throughout day
- Exposure to chemicals, dust, fumes, odor, and hazardous lab waste
-Knowledge and moderate use/application of basic scientific theory and principles.
-Able to apply basic understanding of scientific data/literature to conduct experiments. Able to present ideas for modifying existing procedures and suggestions for using alternative methods to improve results. Some experience with problem-solving and troubleshooting (i.e., OOS investigations)
You will prepare documentation for all laboratory work, evaluate laboratory results, perform analytical testing and train/mentor QC staff as needed. Ideally you will have 21 CFR Part 11 compliance, Excel expertise, and software/spreadsheet validation experience.
This is a stable opportunity with one of the leading companies in its industry. The offer excellent support and a an agile, entrepreneurial environment.
To find out more about Real please visit www.realstaffing.com