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Quality Assurance Specialist

Job Description

Quality Assurance Specialist

Ensuring quality of operations and data being produced in the laboratories by performing data review, auditing laboratories, investigation/corrective action follow-up, and reviewing written procedures; ensuring laboratory adherence to government regulations and client requirements; independently performing duties, both routine and non-routine, completed in a reliable and accurate manner; understanding basics of technical procedures; identifying problems and suggesting solutions; reviewing and approving work of others; maintaining knowledge of current regulations and quality policy requirements; utilizing diplomacy and mediate conflicts; performing sample administration and stability functions

Employee Responsibilities:
  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Perform internal quality assurance audits
  • Participate in external and/or regulatory audits; formulate and prepare responses
  • Administer calibration manager program
  • Perform Sample Unpacking, Entry and Receiving Functions
  • Administer and manage stability studies
  • Perform review and approval of SOP's
  • Review and approve exceptions
  • Administer document control systems
  • Administer CAPA system
  • Administer training records systems
  • Perform GMP/GLP training
  • Administer archiving system
  • Manage GLP studies
  • Prepare SOP's and forms
  • Apply other applicable regulations based on assignment, such as GLP
  • Perform data review (analytical, validation, investigations), review for compliance and identify issues
  • Review quality control (QC) data and nonconformance issues
  • Investigate and document quality assurance (QA), method, and regulatory deficiencies within the lab
  • Perform all QA functions in compliance with quality policy and regulatory requirements
  • Provide administrative support to maintain required certifications and/or accreditations
  • Due to the size of the site employees are required to flex into positions and activities outside their normally assigned duties as workload requires and as trained. These activities require working in all departments including QA, microbiology, chemistry, and general support for laboratory operations.
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned
The Ideal Candidate would possess:
  • Planning, organization, and work management (multitasking) and follow-up skills
  • Quality orientation and attention to detail
  • Quality and safety minded
  • Good technical skills, including the ability to understand analytical methods without actually performing them
  • Communicate effectively both orally and in writing
  • Good judgement, decision making, and problem solving
  • Initiative and innovation abilities
  • Patience; absorb new information; handle stress well
Minimum Qualifications:
  • Bachelor's degree in Chemistry or related science; previous related laboratory or QA experience
  • Computer skills including word processing, spreadsheets, and database
  • Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
  • 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
Position is full-time, Monday-Friday, 8 a.m.-5 p.m. with weekends when necessary; overtime as needed. Candidates currently living within a commutable distance of Portage, Michigan are encouraged to apply.

As a part of Eurofins BioPharma Product Testing - the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide - Eurofins Lancaster Laboratories provides comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. Our service offering includes comprehensive chemistry, biochemistry, microbiology, molecular and cell biology and biosafety testing of drug substances, final products, intermediates, and starting materials for both small and large molecule drug products.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com .

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

Job Snapshot

Employment Type Full-Time
Job Type Science
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Biotechnology, Pharmaceutical
Required Travel Not Specified
Job ID 18000
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Quality Assurance Specialist


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