The QC Analytical Chemist will primarily assist the Production and Formulations Departments by analyzing pharmaceutical samples delivered to the QC laboratory. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support product development, clinical trials, stability studies, and process validations. The QC Analytical Chemist is expected to understand internal procedures and reliably conduct basic analyses with minimal supervision after training. Additionally, the QC Analytical Chemist is expected to assist in maintaining and the operation and calibration of analytical equipment as well as maintain overall cGMP compliance with the QC laboratory.
ESSENTIAL JOB FUNCTIONS:
- Supports new product development, stability studies, and/or process validation.
- Analyzes pharmaceutical samples.
- Assists/performs method development and analytical method validations, transfers or compendial verifications.
- Drafts and edits new or existing internal procedures and specifications.
- Calibrates and maintains QC analytical equipment.
- Performs basic equipment troubleshooting with support from management and/or other lab personnel.
- Maintains a cGMP laboratory notebook and forms.
- Reviews laboratory notebooks and forms of other lab personnel.
- Assists in maintaining a clean, organized QC laboratory.
- Lifts/Carries objects weighing up to 55 lbs.
- Follows all cGMP practices, policies, and procedures.
- Follows all safety practices, policies, and procedures.
- Other duties as assigned.
- Bachelor's Degree in Chemistry or related field.
- Experience with the use and troubleshooting of laboratory equipment desirable.
- Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.
- Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
- Ability to lift objects weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.
Job Status: Full Time