Job Title: QC Analytical Chemist - Level 3
The primary purpose of the QC Analytical Chemist 3 is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. 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. The QC Analytical Chemist 3 is expected to understand internal procedures and reliably conduct analyses with limited supervision.
In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.
ESSENTIAL JOB FUNCTIONS:
- Ensures adherence to Company Standard Operating Procedures, analytical methods, protocols, company standards, and applicable regulations.
- Analyzes pharmaceutical or cleaning samples
- Leads analytical method feasibility, validations, transfers, and verifications
- Advanced understanding and use of Empower software
- Proficient in creating/editing new or existing internal procedures and specifications without assistance
- Trained on at least two of the following: HPLC, GC, dissolution, or applicable advanced instruments
- Analytical Lead on 1-2 projects with some guidance from QC Leadership
- Assists less experienced staff with method training and questions
- Calibrates and maintains QC analytical equipment
- Communicates with Production, Formulations, and QA departments as required
- Maintains a cGMP laboratory notebook, data, forms, and/or logbook.
- Performs basic and complex review in laboratory notebooks, data, or forms
- 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.
- Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities.
- Experience with the use and troubleshooting of analytical equipment (HPLC, GC, and/or dissolution)
- 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.