6-12 month Contract
Based in NC
QC Chemist II is responsible for performing analytical testing and data review activities on inactive and active ingredients, packaging components, and in-process, finished product and stability samples. These activities are designed to ensure that product manufactured, packaged, or marketed by company is safe and meets established quality standards. All activities are performed with a dedicated focus on current good manufacturing practices (cGMP), safety, and regulatory compliance.
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.
1. M.S. in Chemistry or equivalent discipline, OR Bachelors degree in Chemistry or equivalent discipline with appropriate experience (Typically 2 + years),
2. 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)
3. Ability to pritoritize, plan, and schedule activities with multiple functional groups
4. Knowledge of commonly used laboratory instrumentation and software
5. Knowledge of cGMP/cGLP requirements and laboratory safety
6. Computer literacy
7. Lifts and carries laboratory solvents/supplies up to 10-20 pounds
8. Remains standing/on feet for extended durations throughout day
9. Exposure to chemicals, dust, fumes, odor, and hazardous lab waste
Company offers an extremely exciting 6-12+month Consulting Assignment and competitive hourly rate.
For immediate consideration, please email resume to firstname.lastname@example.org