Quality Engineer III - GMP/Deviation Expert

Lancesoft; Greenville (NC); On-site; USD 74,000 - 77,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Contributions

Critical Illness Insurance

Job summary

LanceSoft in Greenville, NC is seeking a Quality Engineer III to join our manufacturing quality team. The role requires evaluating facility, personnel, and documentation to ensure cGMP compliance, with a focus on aseptic processes and deviation management.

You will lead quality reviews, support root cause analyses, and drive continuous improvement initiatives while collaborating with production and QA staff.

Qualifications

• Bachelor’s degree in technology, engineering or microbiology preferred.
• A minimum of 4 years of experience in Quality Assurance/Quality Control/Operations.
• Pharmaceutical industry experience, aseptic or sterile processes preferred.

Responsibilities

• Perform daily quality assessments to ensure quality and compliance per site procedures and cGMPs.
• Troubleshoot and guide aseptic technique; assist with documentation corrections.
• Lead quality reviews and approvals of procedures, training documents, and forms of moderate to high complexity.
• Participate in deviation investigations and root cause analysis; support RAPID events.

Skills

Quality Assurance

Education

Bachelor's degree in technology/engineering/microbiology

Job description

LanceSoft in Greenville, NC is seeking a Quality Engineer III to join our manufacturing quality team. The role requires evaluating facility, personnel, and documentation to ensure cGMP compliance, with a focus on aseptic processes and deviation management.

You will lead quality reviews, support root cause analyses, and drive continuous improvement initiatives while collaborating with production and QA staff.