Quality Control Chemist

Summary

Under the direction of laboratory management, this individual performs tests, assays and measurements of raw materials, in-process samples, finished products and stability samples. This position is responsible for the day-to-day operation of the Chemistry Laboratory and other quality control functions with a Chemistry Lab context.

Essential Duties andResponsibilities

• Maintain detailed and up to date documentation
• Perform routine testing of finished products, raw materials, stability samples and in-house facility samples
• Prepare reagents and solutions in accordance with standard operating procedures
• Provide timely and high-quality data reports that document test results
• Interface, maintain, and populate the LIMS system as needed
• Perform sampling of the RO and DI water systems as needed
• Composite finished products for microbiology/chemistry testing
• Retain raw materials and finished products as required
• Clean laboratory glassware and containers as needed
• Assist with additional testing for R&D, OOS and deviation investigations when required
• Maintain compliance to current standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP)
• Prepare and send samples to outside laboratories for testing as needed
• Provide on-call coverage for non-scheduled work as needed
• Perform other duties, as assigned.

Education, Skills and Experience

• · Bachelor’s degree in Chemistry or a related field.
• · Experience in a Pharmaceutical laboratory testing environment preferred.
• Knowledge of cGMPs and good documentation practices
• Good analytical technique and instrumentation skills
• Well-developed interpersonal skills
• Demonstrated ability to work independently with a strong sense of urgency
• Strong organizational skills with an attention to detail

· Ability to use pH/conductivity meter, Karl Fischer, HPLC, UPLC, FTIR, Ro-Tap, Microtrac, ICP-OES and other related instrumentation

• Proficient in Microsoft Office Word, Excel and Outlook
• Familiarity with Empower 3 Chromatography Data Software and BlazeLIMS Data System