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Lead Quality Control Specialist
2 months ago
We are seeking a highly skilled and experienced Senior Analytical Chemist to join our team at PL Developments. As a key member of our Quality Control department, you will be responsible for performing complex analytical testing and troubleshooting on a wide range of laboratory equipment.
Key Responsibilities- Perform Advanced Analytical Testing: Conduct thorough analysis of raw materials, in-process, and finished products using state-of-the-art laboratory equipment such as HPLC, FTIR, UV, GC, ICP, and Wet Chemistry techniques.
- Troubleshoot and Maintain Equipment: Identify and resolve issues with critical laboratory instruments, ensuring minimal downtime and optimal performance.
- Develop and Validate Test Methods: Collaborate with cross-functional teams to design, develop, and validate new analytical test methods, ensuring compliance with FDA cGMPs, cGLPs, USP, ICH, SOPs, and other recognized standards.
- Train and Mentor Colleagues: Provide guidance and training to laboratory analysts on analytical test method procedures, equipment operation, and documentation.
- Communicate Results and Data: Effectively communicate laboratory test data, data review, and reporting of Out-of-Specification (OOS), Quality Review (QR), and Out-of-Trend (OOT) test results to the laboratory manager.
- Support Laboratory Operations: Participate in the upkeep of laboratory instrumentation, coordinate with calibration services, and contribute to the implementation of the 5S process improvement program.
- Lead Investigations and Reporting: Lead laboratory investigation efforts, draft final reports, and assist with annual management review metrics for Quality Control laboratory functions.
- Education and Experience: Bachelor's degree in Chemistry or Biochemistry, with a minimum of 5-8 years of experience in a FDA-regulated environment, working in a QC laboratory.
- Technical Skills: Strong foundation in analytical techniques, hands-on sample preparation, and operation of analytical equipment and software. Proficiency in HPLC, GC, FTIR, UV Spec, ICP, and other analytical instrumentation. Experience with data analysis (MS Excel) and proficiency in MS Word required.
- Soft Skills: Excellent communication and interpersonal skills, with the ability to work effectively in a team environment. Strong problem-solving and analytical skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
- Work Environment: Employees are required to wear eye protection and lab coats while in the lab. Work safely and follow all OSHA regulations and company safety policies and procedures.
- Physical Demands: Ability to frequently lift and/or move up to 25 lb. Ability to occasionally lift and/or move up to 35 lb. Ability to regularly stand, sit, and walk to perform tasks.
