Quality Assurance Engineer III - Sterile Operations

Lancesoft; Greenville (NC); On-site; USD 64,000 - 91,000; Full time

Benefits offered by this job

Medical Insurance

Dental and Vision Insurance

401k Contributions

Critical Illness Insurance

Voluntary Permanent Life Insurance

Accident Insurance

Job summary

LanceSoft in North Carolina is seeking a Quality Assurance professional to drive quality execution across sterile manufacturing, filling, packaging and inspection for commercial and development products.

The role provides guidance on practical process improvements, conducts quality reviews, supports deviation investigations and champions a culture of quality. Requires a bachelor’s in technology, engineering or microbiology and 4+ years in QA/QC/manufacturing with aseptic experience preferred.

Qualifications

• Bachelor’s degree in technology, engineering or microbiology related field is required or equivalent combinations of education, training and experience
• Minimum 4 years of experience in Quality Assurance or Quality Control or Operations/Manufacturing
• Experience in pharmaceutical industry; aseptic or sterile processes preferred; ISO 9001 experience a plus
• Ability to capture data, analyze and troubleshoot process issues, equipment problems with production leadership
• Ability to lead, support and empower a team
• Technical Writing experience; certifications (CQA) and Six Sigma training are a plus

Responsibilities

• Perform daily QA assessments of facility, personnel, and documentation to ensure quality and cGMP compliance
• Interact with staff to assist with troubleshooting and aseptic technique guidance
• Champion quality culture and policy adherence across operations
• Support deviation events and root cause analysis with QA
• Review and approve procedures, training documents, and changes
• Participate in quality review of batch records and change controls
• Identify continuous improvement opportunities and contribute to process improvements

Skills

Data analysis

Troubleshooting

Team leadership

Technical writing

Root cause analysis

Education

Bachelor’s degree in technology, engineering or microbiology related field

Tools

CQA certification

Six Sigma

Job description

LanceSoft in North Carolina is seeking a Quality Assurance professional to drive quality execution across sterile manufacturing, filling, packaging and inspection for commercial and development products.

The role provides guidance on practical process improvements, conducts quality reviews, supports deviation investigations and champions a culture of quality. Requires a bachelor’s in technology, engineering or microbiology and 4+ years in QA/QC/manufacturing with aseptic experience preferred.