Sr. Quality Control Scientist – Waukegan, IL

Waukegan, IL

Job description:

This 100-year young company is the premier manufacturer of cGMP high purity and low endotoxin injectable carbohydrate excipients (“High Purity Ingredients” or “HPIs”) for the biopharmaceutical and pharmaceutical markets. In addition, the Company specializes in the isolation, purification, custom synthesis, and scale-up development and manufacture of small molecule Active Pharmaceutical Ingredients (API) and High Potency Active Pharmaceutical Ingredients (HPAPI) in gram to multi-ton commercial quantities. The company is seeking a Senior Scientist- Quality Control to Join their growing team!

Responsibilities:

  • Perform testing of raw materials, in-process samples, finished products, stability samples, and cleaning samples in support of the release of materials while striving to adhere to assigned due dates. Assess and prioritize workload without Management supervision.
  • Provide project support through testing requests, compilation and assessment of data, feedback on analysis approach and reporting of findings to supervisor and / or project lead including issues/abnormal observations while striving to adhere to assigned due dates.
  • Perform technical and compliance review of complex analytical tests
  • Execution of testing protocols without deviation
  • Willingness to work on Safebridge Category I-III compounds
  • Perform training of other scientists on complex and/or specialized analytical techniques
  • Requires a full understanding of multiple instruments including functionality and the ability to troubleshoot issues. Review of instrument qualification packets
  • Method troubleshooting of simple analytical methods
  • Authoring of templated and non-templated technical documents
  • Mentoring of junior employees through training and guidance, both scientific and professional
  • Act as a contact point with external clients, to disseminate and/or gather the information from/required by the client and communicate issues/requests/scope changes to project management
  • Act as a primary point of communication up through management
  • Maintain analytical equipment (periodic calibration and maintenance) in accordance with PI policies and procedures
  • Maintain files as directed
  • Perform data entry into spreadsheets and proprietary computer systems
  • Operate following policies and procedures to meet cGMP regulations and ICH guidelines
  • Maintain documentation in an accurate, clear and concise manner in accordance with company policies and procedures
  • Maintain a clean, safe and orderly workplace, following all applicable EHS policies and procedures

Requirements:

  • BS or MS degree in chemistry or biology or related field
  • 7+ years of experience in a GMP analytical laboratory
  • Accurate Documentation and Observation skills
  • Working knowledge of the cGMP regulations preferred
  • Working knowledge of safe handling practices of dangerous chemicals
  • Computer skills (spreadsheet, database, and word processing window-based programs)
  • Hands-on experience with the operation and maintenance of analytical instrumentation preferred. (HPLC and GC using Empower, ICP-MS)
  • Excellent communication skills

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