The Quality Control Chemist II primary responsibility will be to support quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to providing general laboratory support for raw material, in-process, stability, and finished product testing.
- Perform physical, chemical, and instrumental analysis of active pharmaceutical ingredients, excipients and finished pharmaceutical products
- Prepare standards and samples for analysis
- Run the instrumentation independently including, but not limited to, HPLC, FTIR, TOC and physical testing on pharmaceutical products according to client/USP compendia procedures and departmental SOPs
- Independently, or with vendor, troubleshoot instrumentation issues as related to testing
- Perform or schedule preventative maintenance of laboratory equipment as needed
- Data review; ensure that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations
- Process data, generate reports, and evaluate data
- Execute method transfer and validation protocols
- Independently author or edit internal test methods and standard operating procedures.
- Perform trending on a routine basis and compile annual summary results to support quality management systems.
- Perform all job responsibilities in compliance with cGMPs, company SOP’s, and current industry practice.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
BS or BA in Chemistry or related field with a minimum of 3 years of experience within a pharma, biopharma and/or biotech manufacturing environment.
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Ability to work with a diverse customer base
- Ability to work well in a cross functional team environment
- Must have proficient computer skills in Microsoft Word, Excel and Outlook
- Ability to read and execute compendia methods from USP, preferably EP as well
If you would like to be considered, please submit your resume on our careers page.