Quality Lab Associate - Spark Life Solutions : Job Details

Quality Lab Associate

Spark Life Solutions

Job Location : Round Lake,IL, USA

Posted on : 2024-12-10T01:34:24Z

Job Description :
Roles & Responsibilities:
  • Perform critical chemical and physical analyses on raw materials, in-process samples, and final products.
  • Conduct testing for environmental monitoring programs at the manufacturing facility.
  • Mentor and provide training to Quality Laboratory Associate (QLA) I positions.
  • Perform and review test data for documentation accuracy and compliance.
  • Conduct release functions in LIMS or similar computerized systems.
  • Operate advanced laboratory instrumentation (e.g., HPLC, GC) and collect data using computer systems.
  • Perform advanced chemical assays with a strong understanding of biology and chemistry principles.
  • Ensure testing is completed timely, including special project/protocol testing.
  • Maintain data integrity and ensure compliance with FDA, GLP, QSR, and cGMP regulations.
  • Participate in team-based improvement initiatives to enhance production efficiency, solve problems, and improve quality.
  • Audit and update SOPs, perform equipment maintenance/calibrations, and document test completion accurately.
  • Investigate deviations and author exception reports (OOL/OOS/OOT).
  • Support improvement projects using LEAN management principles (6S, Kaizen, etc.).
  • Maintain a clean, safe, and organized lab area, ensuring compliance with SOPs and safety policies.
Education & Experience:
  • Bachelor's degree in Chemistry or a physical science with 2+ years of relevant experience.
  • Strong oral and written communication skills.
  • Proficiency in advanced laboratory skills and basic statistical methods.
  • Knowledge of GLP, cGMP, and USP/ICH guidelines (preferred but not required).
  • Experience with Empower Chromatography Data System and LIMS (preferred but not required).
  • Strong technical problem-solving and multitasking abilities.
  • Effective training, leadership, and task completion skills.
  • Ability to work independently and as part of a team in a dynamic environment.
  • Physical ability to lift up to 50 pounds and work occasional weekends.
  • Must not be color blind or allergic to Penicillin or Cephalosporin drugs.
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