Pharma Quality Assurance Engineer (Aseptic/GMP)

Lancesoft

Greenville (NC)

On-site

USD 74,000 - 79,000

Full time

4 days ago
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Benefits offered by this job

Medical insurance (4 options)
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks

Job summary

LanceSoft is seeking a Quality Assurance/Quality Control professional for a 9-month onsite assignment in North Carolina. The role focuses on ensuring cGMP compliance, data-driven quality reviews, and continuous improvement across manufacturing and documentation. Strong aseptic process experience and a relevant degree are required.

Responsibilities include troubleshooting, deviation handling, root cause analysis, and collaboration with production leadership to uphold quality standards.

Qualifications

  • Bachelor's degree in technology, engineering or microbiology required.
  • Minimum 4 years of QA/QC/Operations experience.
  • Pharmaceutical industry and aseptic/sterile processes strongly preferred.
  • Data capture, analysis and troubleshooting of process issues.
  • Professional certifications (e.g., CQA) and Six Sigma training a plus.

Responsibilities

  • Perform daily quality assessments to ensure quality and cGMP compliance.
  • Assist with troubleshooting, documentation corrections and aseptic technique guidance.
  • Champion quality culture by enforcing policies and controls.
  • Participate in RAPID events and deviation guidance.
  • Advance deviation events to quality management.
  • Quality review/approval of procedures, training docs and forms.
  • Quality review of deviation and change controls.
  • Participate in Root Cause Analysis for deviations.
  • Perform quality batch record review.
  • Identify continuous improvement opportunities and contribute to process improvements.

Skills

Data analysis
Troubleshooting
Technical writing
Leadership
Quality Assurance

Education

Bachelor's degree in technology/engineering/microbiology
Equivalent combinations considered

Job description

LanceSoft is seeking a Quality Assurance/Quality Control professional for a 9-month onsite assignment in North Carolina. The role focuses on ensuring cGMP compliance, data-driven quality reviews, and continuous improvement across manufacturing and documentation. Strong aseptic process experience and a relevant degree are required.

Responsibilities include troubleshooting, deviation handling, root cause analysis, and collaboration with production leadership to uphold quality standards.

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