What are the responsibilities and job description for the Quality Assurance Specialist I position at LGC Group?
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 nonconformances 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 onthefloor support including inspection of raw materials and finished product
Knowledge Experience and Technical Skills
Qualifications :
Education and / or Experience
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work : Employment Type :
Fulltime
Key Skills
Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration
Vacancy : 1
