Quality Assurance Specialist

4 weeks ago


Grand Haven, Michigan, United States Beacon Hill Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Beacon Hill. As a Quality Assurance Specialist, you will be responsible for performing tests, assays, and measurements of raw materials, in-process samples, finished products, and stability samples.

Key Responsibilities

  • Maintain accurate and up-to-date documentation of laboratory activities
  • 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

Requirements

  • 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


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