Chemist II; Quality Control

Description

Position Summary:

The Chemist II is responsible for and has a moderate level of experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs.

Responsibilities: Responsibilities include, but are not limited to: 

• Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc. 
• Perform laboratory chemical analysis on raw materials, in-process materials, and/or finished product, using ICP-OES/MS, UV-Vis, Fluorescence, GC, HPLC/UPLC, titration, and other wet chemistry techniques, as assigned, in accordance with the prescribed approved analytical test method.
• Execute assay testing, content uniformity testing, impurities analysis, method transfers, cleaning validation testing, and process/interpret data at a moderate level with minimal to no errors.
• Maintain a clean and organized laboratory working environment.
• Dispose of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles.
• Report well-written, accurate and timely results.
• Review data, calculations, notebooks, and reports.
• Assist in laboratory investigations, as assigned.
• Assist in Process validation testing and protocol/report review, as assigned.
• Maintain and troubleshoot laboratory equipment at a moderate level.
• Suggest improvements to existing testing methods when possible.
• Assist with routine Metrology functions, including instrument cleaning/ preventive maintenance/ calibration/ verification activities.
• Monitor and assist with maintaining proper inventory levels of all laboratory supplies.
• Assist with sample receiving, chemical inventory, document filing, housekeeping, etc.
• Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.
• Other responsibilities as assigned by Management.

Requirements

Education and Experience:

• Bachelor’s degree in a science related field.
• Between 4 - 8 years of work experience in a laboratory setting preferred.

Skills, Knowledge, and Abilities:

• Knowledge of laboratory chemistry and cGMPs.
• Proficient in Microsoft Word, Excel, graphs/charts and databases.
• Proficient in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, and wet chemistry testing.
• Proficient with analytical laboratory software.
• Able to multitask and meet tight deadlines.
• Excellent organizational skills with attention to detail.
• Able to effectively present results.
• Able to perform testing on moderate level methods and troubleshoot moderate method issues. May require some guidance/supervision as needed. 
• Able to troubleshoot moderate instrument issues independently, and complex instrument issues under supervision.

Physical Demands:

• Required to sit and stand for long periods of time. 
• Frequently reaching with arms/hands up to 2 feet. 
• Good hand eye coordination. 
• Occasionally required to walk and kneel.
• Must be able to lift and/or move up to 50 pounds.
• Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus. 
• Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs.

Work Environment:

• Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders.
• Potential to move between production operations sites/areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle. 
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers.

Supervisory Responsibilities:

• None

Personal Protective Equipment or Attire Required for Position: 

• Gowning as required by GMPs and/or SOPs.

 Pay Range:  

• $75,000 - $89,999 per year