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 and Responsibilities
- 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
