The Quality Control Chemist II (QCCII) is an integral member of our Quality Control (QC) team, reporting directly to QC Management. This role is responsible for ensuring the accuracy, precision, and robustness of testing methods and instrumentation, as well as conducting various quality control testing activities to ensure product integrity.
***There is also a QC Chemist I opening that requires 0-5 years experience***
- Method Development and Optimization: Collaborate in evaluating new testing applications and instrumentation, participating in the development of new methods, or adopting established compendial methods. Assist in transferring new methods for routine QC use.
- Analytical Expertise: Utilize a strong understanding of experimental design, chemical theory, and analytical instrumentation, including HPLC, GC, ICP-MS/ICP-OES, to ensure the reliability and accuracy of testing.
- Routine QC Functions: Demonstrate knowledge of all QC routine functions and perform them reliably. Independently execute in-house methods and procedures with minimal assistance.
- Testing Activities: Conduct release, stability, and special request testing of finished products and raw materials following SOPs, in-house test methods, or compendial methods.
- Decision-Making: Make informed decisions based on facts, experience, and sound judgment to ensure product quality.
- Project Management: Independently manage projects assigned by management within established time frames.
- Regulatory Compliance: Stay updated on publications released by USP, FDA, and other relevant regulating bodies to ensure compliance with analytical applications, release specifications, and documentation practices.
- OOS Resolution: Assist laboratory personnel in resolving Out of Specification (OOS) results following laboratory investigation procedures when assigned.
- Training: Contribute to the training of new laboratory personnel and maintain accurate training documentation in accordance with established laboratory SOPs and the Nutramax training program.
- cGMP Compliance: Follow current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures promptly. Ensure the calibration and proper maintenance of testing equipment.
- Additional Duties: Fulfill any other assigned duties required to meet company objectives.
- Collaboration and Communication: Effectively communicate and collaborate with other departments within the organization, fostering a team-oriented environment.
- Attendance: Maintain regular attendance as a fundamental aspect of this role.
- Experience: Five or more years of laboratory experience in a cGMP facility, including proficiency in operating laboratory instrumentation such as Gas Chromatography (GC) and/or Liquid Chromatography (LC). Experience in troubleshooting, project management, SOP and test method generation and revision, as well as method optimization, validation, and development is essential.
- Skills: Effective interpersonal skills, self-motivation, strong communication abilities, and the capacity to interact with personnel at all levels are necessary for success in this role.
Education and Experience:
- A Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field, preferably Chemistry, Biochemistry, or Biology.