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Quality Assurance Specialist Ii

4 months ago

Gaithersburg, Maryland, United States LGC Limited Full time
LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics and the Native Antigen Company.

Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK.

LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.


  • Provide QA support on cross functional teams in investigations of deviations, nonconformances, OOSs, and CAPAs to determine root cause and implement corrective actions to mitigate root causes; work constructively with functional groups to determine root causes for process issues related to products and services.
  • Ensure accurate QMS records related to nonconformances, deviations, customer complaints, OOSs, reworks, and CAPAs; work with functional groups to determine root causes for process issues related to products and services.
  • Investigate quality issues and trends from customer complaints, NCRs, CAPAs, etc. to identify actions required.
  • Perform product release activities such as review of batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
  • Review risk management documentation and actions for completeness, feasibility, and adequacy. Track mitigation efforts to reduce risks to acceptable levels.
  • Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods.
  • Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
  • Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.
  • Provide support on quality concepts and tools.
  • Update and track metrics for trending and reporting.
  • Provide QA onthefloor support including inspection of raw materials and finished product.

Qualifications:

  • Bachelor's Degree in a scientific discipline, or Associate's Degree in a scientific discipline with at least 35 years' Quality Assurance experience in a serology, immunochemistry, and/or molecular biology work environment.
  • A minimum of 35 years of experience in a cGMP environment governed by 21 CFR 210/211, 21 CFR 820, or ISO 13485.

Additional Information:

What we offer (US based-employees):

  • Competitive compensation with strong bonus program
  • Great gym onsite
  • Comprehensive medical, dental, and vision benefits for employees and dependents
  • FSA/HSA Pretax savings plans for health care, childcare, and elder care
  • Deductible Buffer Insurance and Critical Illness Insurance
  • 401(k) retirement plan with matching employer contribution
  • Companypaid short
- and long
- term disability, life insurance, and employee assistance program

  • Flexible work options
  • Pet Insurance for our furry friends
  • Enhanced Parental leave of 8 additional weeks
  • PTO that begins immediately
  • Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more
All your information will be kept confidential according to EEO guidelines.