The primary purpose of a QC Analytical Chemist - FP/RM Level 2 is to provide analytical support to the Production and Formulations Departments. This support is provided by analyzing chemical samples and/or developing/validating methodologies for various compounds and components according to compendial monographs, internal specifications, client procedures, and miscellaneous research procedures.
In addition, the QC Analytical Chemist - FP/RM Level 2 assists in maintaining the operation and calibration status of analytical equipment as well as maintains overall cGMP compliance within the QC laboratory. The OC Analytical Chemist - FP/RM Level 2 is expected to possess a more thorough understanding of laboratory procedures, reliably conduct more complex analyses, and assigned projects with little or no supervision.
ESSENTIAL JOB FUNCTIONS
Supports Finished Goods/Raw Materials product testing by performing both Compendia (i.e. SUP, NF, EP, etc.,) and client supplied methods.
Performs analytical method validations, transfers, and verifications.
Assists Level 1 Chemists with basic tasks.
Drafts protocols, methods, master specifications, and SOPs as needed.
Verifies quotes as needed.
Calibrates and maintains QC analytical equipment.
Maintains a cGMP laboratory notebook and forms.
Reviews laboratory notebooks and forms of other lab personnel.
Lifts/Carries objects weighing up to 55 lbs.
Follows all CPI cGMP practices, policies, and procedures.
Follows all CPI safety practices, policies, and procedures.
Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
Bachelor's degree in chemistry or related field.
2+ years of experience at Coating Place, Inc. or in a cGMP pharmaceutical environment. An advanced degree may be substituted in place of experience.
Experience with the use and troubleshooting of QC analytical equipment (i.e. HPLC, GC, and/or dissolution apparatus) desirable.
Advanced 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.