• Leadership
  • Serves as a subject matter expert for Quality Control instruments and processes.
  • Provides guidance and input as a certified co-investigator for Laboratory Incident Reports.
  • Leads as a mentor and trainer for Quality Control testing, instrument maintenance, investigational writing, and other laboratory processes.
  • Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.
• Quality
  • Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
  • Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas
    • Preparation includes review of logbooks for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area.
  • Participates in regulatory audits as a subject matter expert as needed.
  • Executes laboratory, non-conformance, and CAPA investigations as assigned by management in compliance with procedures.
  • Maintains status as a certified investigator for Out of Specification investigations.
  • Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
• Documentation/Training
  • Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
  • Recommends and authors revisions to QC department standard operating procedures (SOPs) and executes in implementation.
  • Ensures personal training is maintained to current department processes and procedures.
  • Trains and mentor’s teammates on Biochemistry laboratory testing, processes, and procedures.
  • Maintains status as a certified trainer for laboratory testing processes.
• Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
• Continuous Improvement
  • Participate in continuous improvement activities.
    • Identify areas of deficiency and implement practices to improve employee safety, ergonomics, workflow/process design, etc.
    • Lead improvement initiatives as directed by management.
  • 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times in compliance with cGLP.
• Other Duties
  • Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.
  • Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

• Bachelor's degree with 4+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.
  
  • In lieu of a Bachelor’s Degree, a high school diploma/GED with 8+ years of experience OR an Associate’s Degree with a minimum of 6+ years of experience working in a regulated laboratory environment are also accepted
  • Technical writing experience is highly desired - Nonconformance, Laboratory Investigative Reports, CAPAs, Deviations, and SOPs
  • Experience troubleshooting equipment and instrumentation is highly preferred (HPLC, GC, PH, UV-VIS, or similar)
• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.
• Experience with applicable instrumentation and troubleshooting.

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