Quality Lab Associate II
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Job Title: Quality Lab Associate II
Job Description & Responsibilities
- Conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of raw materials, initial, in-process and final product samples from the manufacturing facility, as required. Work under minimum supervision.
- Perform review of test data, which includes overall documentation practices. Perform review functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required conduct validations.
- Perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
- Investigate deviations and write exception documents.
- Participate in cross functional teams, which may impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
- Maintain laboratory safety requirements and perform laboratory audits as required. Audit SOPs and update, as required.
- Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.
Skills, Experiences, Knowledge
- Bachelor’s degree in Chemistry or biological science with analytical chemistry laboratory coursework and at least 2-5 years’ recent and relevant experience, or Master’s Degree in Chemistry, or Biological Sciences.
- A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
- Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
- Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion.
- Must be able to handle multiple tasks concurrently and in a timely fashion.
- Must communicate effectively with managers, peers, and subordinates.
- Interpret available information and make recommendations to resolve technical challenges.
- Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, GC, pH, KF, TOC, AA, GFAA, titrations, etc.)
- Pharmaceutical GMP/QC laboratory experience.
- Possess excellent quantitative analytical chemistry techniques.
- Normal visual acuity and ability to distinguish color are necessary.
- Must be able to lift and carry on average up to 15 pounds, stand for prolonged periods, and perform repetitive processes using both arms and hands.
- When working with pharmaceutical drugs, must enter health surveillance program and meet occupational health clearance to perform essential duties of the job.
- Ability to work in team oriented, dynamic fast-paced environment with competing priorities and due dates.
- Stability study execution experience is desired.
- Validation / Method Transfers experience is desired.