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Senior Quality Assurance Specialist: Second Shift

Company: Eurofins
Location: Lancaster
Posted on: June 10, 2021

Job Description:

Job Description

  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
  • Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
  • Review Instrument qualifications to ensure that work is performed as per the procedure
  • Review GLP data for adherence to GLP regulations
  • Review and verify invalid data and system suitability failures
  • Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
  • Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
  • Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
  • Support other QA compliance-related activities, as needed
  • Communicate in writing and in person with laboratory personnel in an intelligent and clear manner
  • Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
  • Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
  • Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
  • May serve as technical advisor for analysts with regard to QA/QC of data
  • Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
  • Support other QA compliance-related activities, as needed
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned

Qualifications

Basic Minimum Qualifications:

  • Bachelor's degree in ascience-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • At least three years of laboratory experience with knowledge of regulatory requirements
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, Monday - Friday 2:00pm - 10:00pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.

  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins, Lancaster , Senior Quality Assurance Specialist: Second Shift, Other , Lancaster, Pennsylvania

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