Senior Quality Assurance Specialist — Flexible Work & Growth

LGC; Alexandria (MN); Presencial; USD 39.000 - 48.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k) plan

PTO starting

Descripción de la vacante

LGC is seeking aQuality Assurance Specialist in the United States to provide advanced QA support across manufacturing and QA, ensuring products, processes, and documentation meet internal, customer, and regulatory standards. The role involves reviewing release records, leading investigations, and supporting CAPAs with cross-functional teams.

The position emphasizes risk-based decision making, ISO 9001 and ISO 13485 compliance, and collaboration with multiple departments to maintain an effective

Formación

• Associate’s degree in a Technical, Scientific, Quality, or related field — or equivalent combination of relevant education and applicable work experience.
• 5+ years of experience in a cGMP or regulated environment, eg. governed by ISO 9001, or ISO 13485.
• Experience in root cause analysis and corrective action within a GMP setting.
• Direct audit experience as either a lead auditor or part of the audit team.
• Prior experience in the medical device, biotechnology, or biopharma industry; ISO or FDA-certified manufacturing environment is a plus.
• Demonstrated experience with electronic platforms for quality management systems.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Strong analytical and problem-solving capabilities with attention to process mapping and data documentation.

Responsabilidades

• Review and approve quality and product-release records, including batch records and QC results, for compliance with internal specs and customer requirements.
• Investigate quality issues, nonconformances, deviations, and customer complaints; collaborate with cross-functional teams for root cause and corrective actions.
• Initiate and support CAPAs, document investigations, monitor implementation, and ensure timely resolution.
• Review quality data to identify trends, risks, and opportunities to improve product quality and process performance.
• Perform internal and supplier audits and issue audit reports; follow up on corrective actions.
• Review and approve Document Change Requests (DCRs) related to materials, processes, and test methods.
• Initiate SOP changes to streamline quality system processes and improve efficiency.
• Support new product development and design-control activities through cross-functional reviews and QA deliverables.
• Provide training on quality concepts and tools; participate in external audits as needed.
• Maintain risk management activities and track mitigation to reduce medium/high risks.

Conocimientos

Root cause analysis

Auditing

CAPA

Quality systems

Problem solving

Educación

Associate’s degree in Technical/Scientific/Quality field

Herramientas

Microsoft Office

Descripción del empleo

LGC is seeking aQuality Assurance Specialist in the United States to provide advanced QA support across manufacturing and QA, ensuring products, processes, and documentation meet internal, customer, and regulatory standards. The role involves reviewing release records, leading investigations, and supporting CAPAs with cross-functional teams.

The position emphasizes risk-based decision making, ISO 9001 and ISO 13485 compliance, and collaboration with multiple departments to maintain an effective