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Lab Investigation Analyst

Company: Accupac
Location: Lakewood
Posted on: November 18, 2022

Job Description:

Basic Job Functions Provide 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 investigation Minimum 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 Responsibilities No Travel None Education/Experience Quality 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.Job Type: Full-timePay: $75,000.00 - $85,000.00 per yearSchedule: 8 hour shift Day shift Monday to FridayExperience: Technical writing: 2 years (Required)Work Location: Hybrid remote in Lakewood, NJ 08701

Keywords: Accupac, Lakewood , Lab Investigation Analyst, Healthcare , Lakewood, New Jersey

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