Quality Assurance Specialist I

Job Description

Job Purpose

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
• Knowledge, Experience and Technical Skills
• Focused on problem solving, including problem definition, risk evaluation, and risk-based resolution. Root cause analysis expertise.
• Strong interpersonal, organizational, verbal and written communication skills.
• Demonstrates curiosity, adaptability and commitment; 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 flexibility in systems based on risk.
• Impeccable attention to detail.
• Strong analytical and examination capabilities for complex projects desired; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.
  
  

Qualifications

Education and/or Experience

• Bachelor’s Degree or Associate’s Degree with at least 2 years Quality Assurance experience.
• 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

All your information will be kept confidential according to EEO guidelines.