Laboratory Quality Assurance Specialist - Gaithersburg, MD, United States - BuildSubmarines

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.

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. 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.
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.
Provide QA on-the-floor support including inspection of raw materials and finished product.

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.

Comprehensive medical, dental, and vision benefits for employees and dependents
FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
401(k) retirement plan with matching employer contribution
Company-paid short- and long- term disability, life insurance, and employee assistance program
Flexible work options
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.