Senior QA Specialist – GMP, ISO 13485 & Audits

LGC Group; Alexandria (MN); On-site; USD 39,000 - 48,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) retirement plan

Flexible work options

PTO

Job summary

LGC Group is seeking a Quality Assurance Specialist in the United States to provide advanced QA support across manufacturing and regulatory affairs. The role reviews quality records, leads investigations, supports internal and external audits, and improves processes in line with ISO 9001 and ISO 13485.

Responsibilities include approving release records, investigating quality issues, initiating CAPAs, and tracking risk mitigation. Strong collaboration with cross-functional teams is essential.

Qualifications

• 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, e.g. 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
• Demonstrated experience with electronic platforms for quality management systems

Responsibilities

• Review and approve quality and product-release records to verify compliance with internal specifications and customer requirements
• Investigate quality issues, nonconformances, deviations, and customer complaints with cross-functional teams
• Initiate and support CAPAs, documenting investigations and monitoring implementations
• Review quality data and metrics to identify trends and risks and improve product quality and QMS effectiveness
• Perform internal and supplier audits, issue audit reports, and close out actions

Skills

Experience in cGMP environment

Root cause analysis

Audit experience (lead auditor or team

Education

Associate’s degree in technical/scientific/quality field

Tools

QMS software

Job description

LGC Group is seeking a Quality Assurance Specialist in the United States to provide advanced QA support across manufacturing and regulatory affairs. The role reviews quality records, leads investigations, supports internal and external audits, and improves processes in line with ISO 9001 and ISO 13485.

Responsibilities include approving release records, investigating quality issues, initiating CAPAs, and tracking risk mitigation. Strong collaboration with cross-functional teams is essential.