QA Specialist I — 3PL Audits & Compliance Pro

LifeScience Logistics

Atlanta (GA)

On-site

USD 55,000 - 85,000

Full time

2 days ago
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Job summary

LifeScience Logistics seeks a Quality Assurance professional with a BS in Engineering, Science, Logistics, or related field. 1–3 years in quality or logistics and experience with audits, cGMP, and CAPAs are valued.

The role covers regulatory inspections, change controls, recalls, and continuous improvement in a fast-paced 3PL setting. The candidate will work with systems like COMPLIANCE QUEST, Tecsys Elite, and WebCTRL; travel up to 10% is possible.

Qualifications

  • Strong understanding of quality systems and regulatory compliance.
  • Effective time management and communication skills.
  • Ability to conduct research and present findings clearly.
  • Public speaking and presentation abilities.
  • Attention to detail and organizational skills.
  • Ability to travel up to 10%.

Responsibilities

  • Provide support during regulatory FDA, DEA, State inspections and customer audits.
  • Plan and present Quality System information to internal and external groups.
  • Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance.
  • Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
  • Be a part of the internal audit team and assist in external audits.
  • Release quarantined product upon receipt of documentation and use Hold and Release process, participate in Recall.
  • Review/approve product-specific paperwork per Client guidelines, Deviations and CAPAs.
  • Assist in Operations and Facilities to determine root cause and develop corrective actions.
  • Revise SOPs and WIs for process improvements.
  • Perform Gemba walks applying Six Sigma concepts.
  • Participate in cross-functional initiatives for a 3PL environment.
  • Strong leadership skills and logistics knowledge (3PL).
  • Communicate professionally with customers/clients.
  • Assist in returns and damages process.
  • Perform record reviews to ensure procedural compliance.
  • Take part in Inventory System Management after-hours rotation.
  • Assist in validation projects.
  • Be on call for WebCTRL temperature monitoring on a rotation.
  • Generate and review temperature monthly reports.
  • Other duties as assigned.

Education

Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred

Tools

COMPLIANCE QUEST
Tecsys Elite
WebCTRL

Job description

LifeScience Logistics seeks a Quality Assurance professional with a BS in Engineering, Science, Logistics, or related field. 1–3 years in quality or logistics and experience with audits, cGMP, and CAPAs are valued.

The role covers regulatory inspections, change controls, recalls, and continuous improvement in a fast-paced 3PL setting. The candidate will work with systems like COMPLIANCE QUEST, Tecsys Elite, and WebCTRL; travel up to 10% is possible.

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