QA Specialist I: Regulatory & Audit Champion

Lifescience-Logistics; Atlanta (GA); On-site; USD 65,000 - 95,000; Full time

Job summary

LifeScience Logistics is seeking a Quality & Regulatory Specialist to support FDA, DEA, and state inspections, lead internal and external audits, and present Quality System information to diverse groups. This role operates in a fast-paced 3PL environment requiring hands-on problem solving and strong ownership.

You will manage change controls, recalls, deviations, CAPAs, and validations, revise SOPs/WIs, perform Gemba walks, and coordinate with Operations and Facilities to resolve root causes.

Qualifications

• Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred.
• Demonstrated knowledge of 3PL audits and complaints procedures is preferred.
• Validation and DEA experience strongly preferred.

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 from Client and use Hold and Release process, take part in Recall.
• Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs.
• Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities.
• Revise SOPs and WIs for process enhancement.
• Perform Gemba walk applies six sigma concepts such as 5S’s.
• Participate in cross-functional initiatives for a 3PL environment.
• Strong leadership skills and logistics (3PL) knowledge.
• Able to professionally communicate with customers/clients.
• Assist in returns and damages process.
• Perform record reviews to ensure compliance with all applicable procedures and regulations.
• Take part on ISM (Inventory System Management) after hours rotation program.
• Assist in validating projects.
• Being able to be on call for WebCTRL temperature monitoring on a rotation program.
• Assist in generating and reviewing temperature monthly reports in a timely manner.
• Other duties as assigned.

Skills

Leadership

Communication

Attention to detail

Critical thinking

Public speaking

Ownership

Fast-paced environment

Education

BS in Engineering/Science/Logistics or related field

Tools

COMPLIANCE QUEST

Tecsys Elite

WebCTRL

Job description

LifeScience Logistics is seeking a Quality & Regulatory Specialist to support FDA, DEA, and state inspections, lead internal and external audits, and present Quality System information to diverse groups. This role operates in a fast-paced 3PL environment requiring hands-on problem solving and strong ownership.

You will manage change controls, recalls, deviations, CAPAs, and validations, revise SOPs/WIs, perform Gemba walks, and coordinate with Operations and Facilities to resolve root causes.