Quality Assurance Specialist II

Company Description

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.

Job Description

• Provide QA support on cross functional teams in investigations of deviations, non-conformances, 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 non-conformances, 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 on-the-floor 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 3-5 years’ Quality Assurance experience in a serology, immuno-chemistry, and/or molecular biology work environment.
• A minimum of 3-5 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 Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid 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.