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Quality Control Analyst
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Lenox Executive Search
Thousand Oaks, CA (In Person)
$109,200 Salary, Full-Time
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Job Description
Quality Control Analyst Lenox Executive Search Newbury Park, CA Job Details Full-time | Contract $50 - $55 an hour 6 days ago Qualifications Microbiology Laboratory information management systems Microbiology Bachelor's degree Manufacturing FDA regulations Full Job Description Primary Duties of a
Education and/or experience Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred Minimum 2 years of related work experience Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
Quality Control Analyst:
Lenox Executive Search is seeking a QC Analyst II for aCONTRACT
role with one of our global pharmaceutical clients. Key responsibilities are to execute analytical method transfers, including raw materials, for use in a cGMP environment in Quality control. You will be responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, drug substance and final product samples and other samples collected from manufacturing areas.Essential Duties and Responsibilities:
Conduct biological, chemical, and physical analyses on samples including raw materials, initial, in-process and final products, and samples collected from environmental monitoring according to SOP and pre-approved protocols. Drive implementation of new methodologies, or new sample types into existing methods in a QC laboratory Support Investigation of nonconformances and troubleshoot unexpected results. Handle multiple tasks concurrently including testing and inventory management in a timely and appropriate manner. Perform review of test data, which includes overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems. Support generation and documentation of validation protocol deliverables. Draft and update, as required, QC SOPs. Perform test equipment, equipment maintenance and calibrations as required. May perform other duties as assigned. Qualifications General understanding & knowledge of the following areas: o Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.o Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.o Wet and instrumental methods of analyses.o Operating and troubleshooting procedures for lab equipment General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred. Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus. Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis is a plus. Solid team player, able to meet deadlines and changing priorities. Able to communicate effectively with managers, peers and subordinates. Very detailed oriented and able to produce high quality of work. Good interpersonal skills and be able to work effectively and efficiently in a team environment. Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines. Strong decision-making skills, technical problem-solving ability, and analytical skills.Education and/or experience Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred Minimum 2 years of related work experience Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.