Quality Assurance Specialist I

Company Description

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

Job Description

The QA Specialist I position will advance LGC Clinical Diagnostics’ purpose of understanding disease to  enable  precision  diagnostics  by supporting and contributing to LGC Clinical Diagnostics’ product quality and Quality Management System processes. LGC Clinical Diagnostics’ Milford location is seeking a candidate who is experienced with a working knowledge of quality system requirements, including FDA QSR/cGMP, ISO 13485 and ISO 14971. The successful candidate will have a strong orientation toward root cause analysis, continuous improvement based on predictive and preventive metrics. The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance.

Key Responsibilities

• Provide QA support on cross functional teams in investigations of deviations, nonconformances, OOS, 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, OOS, 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

Minimum Qualifications:

• Bachelor’s Degree with at least 2 years Quality Assurance experience.
• Passionate about addressing issues, which involves defining problems, assessing risks, and finding risk-based solutions. Proficient in root cause analysis.
• Strong interpersonal, organizational, verbal and written communication skills.
• Demonstrates curiosity, adaptability and dedication; works best in a team environment and actively seeks to foster relationships.
• Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process.
• Oriented to continuous improvement with desire to balance the level of control and flex