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Lab Investigator

Company: Accupac
Location: Lakewood
Posted on: November 22, 2022

Job Description:

Basic Job FunctionsProvide support to Laboratory Services (Laboratory investigations, review SOPs, protocols, reports, data, records generated and other quality-related documents) for the manufacturing and distribution of product.Essential Functions of the Job - Participate in analytical laboratory investigations (OOS) and other non-conformance investigations (NIR) as assigned - Gather and analyze critical data generated by Lab Services (raw data, chromatography, calculations, data trend study) and review in LIMS - Review Test methods and Laboratory notebooks and/or LIMS for accuracy - Analyze instrument performance, column age, previous failures to support investigations - Maintain and log LIR's in spreadsheets to track the completion of the quality events - Conduct personnel interviews and system reviews as a part of investigation - Observe analytical testing for investigations - Prepare investigation reports as per local SOP and FDA guidelines and confirm applicable approvals - Compile documentation from Laboratories, Manufacturing, and Packaging to support investigations and quality events as needed - Determine conclusions based on the analysis of the data, prepare investigation reports, and assign effective CAPAs - Summarize and complete the Laboratory Investigation Report (LIR) with a scientific, assignable root cause. Complete and update the LIR spread sheets in a timely manner - Communicate effectively with customers, project managers and Lab Management - Assure timely closure of LIRs, CAPAs, assist in performing effectiveness checks - Review records to ensure meets the industry requirements for data integrity - resolve any discrepancies - Ensure procedures are followed as outlined per FDA, ICH, Standard Methods, SOPs, and the Quality Systems' requirements - Support Management with internal and external audits. - Perform other quality-related duties as assigned. - Maintain and Publish Monthly metrics on Laboratory investigationMinimum Requirements of the Job

  • Excellent Investigative skills such as analytical problem solving and root cause analysis by using iterative interrogative techniques like Five whys, Fishbone diagram, etc. Prior experience in Laboratory investigation is a plus.
  • Ability to read, write, understand, and communicate in English. Prior experience in technical writing is preferred.
  • Proficient computer skills and typing
  • Comfortable with working in an analytical testing laboratory atmosphere and proficient with common laboratory equipment/instrumentation, tools, reagents, etc.
  • Effective analytical and problem-solving skills. Must be able to clearly communicate technical, scientific, and regulatory information, both written and verbally
  • Clear understanding of analytical testing. Familiarity of USP/EP/FCC test methods is a must
  • Experience in a pharmaceutical and regulated environment is a must
  • Must have experience with Digital Documentation Management System (DMS) and LIMS
  • Knowledge in operating Total Chrom and Open Lab software is desired.
  • Comply with all company policies, SOPs, cGMP, GLP, GDP and relevant industry, regulatory and safety requirements
  • Maintain internal training at or above 95% of assigned curriculum
  • Demonstrate Good Documentation Practices
  • Working knowledge of MS Office applications (PowerPoint, Word, Excel, Outlook etc.)
  • Performs all tasks with integrity. Candidate must be meticulous and organized.
  • Ability to be flexible with changing priorities in a dynamic environment.
  • Ability to work independently, as well as in a team, to meet deadlines as assigned.
  • Candidate will be cross trained in other Quality System functions as needed
    Physical Requirements
    • Good eyesight (with correction) and hearing (ability to hear alarms, ringing).
    • Frequent contact with chemicals used for testing in the analytical laboratory.
    • Walking/Standing/Sitting for longer periods of time
    • Bending/stooping.
    • Lift/carry items up to 30 pounds.
    • Pushing/pulling items up to 25 pounds.
      Supervisory ResponsibilitiesNoTravelNoneEducation/ExperienceQuality Systems Associate/Lead Investigator-Lab Services must have earned a Bachelor of Science degree (Analytical Chemistry/Chemistry courses required), and 5+ years of Quality experience in a related field with at least a few years of hands-on lab experience.

Keywords: Accupac, Lakewood , Lab Investigator, Healthcare , Lakewood, New Jersey

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