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Sr. Deviation Specialist

HTi LLC
Greenville, SC Temporary
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/13/2025

HTI is seeking a Senior Deviation Specialist for PAI Pharma, a large manufacturer of prescription and OTC pharmaceuticals. Leveraging cutting-edge technology to produce the best-in-class suspensions and oral solutions, this manufacturer has been recognized for being a leader in innovation, quality, and safety. Understanding it is their employees who make the true impact, this organization is known for their commitment to being an employer of choice - offering competitive pay, benefits, and a positive environment for employees at any level!

What They Offer :

  • Full benefits package - Medical, Dental, Vision, EAP, 401k Match
  • Onsite Wellness Center
  • Tuition Reimbursement
  • 13 Paid Holidays
  • Progressive PTO Plan

What You Need :

  • Bachelor's degree in Life Sciences, Chemistry, or Engineering preferred.
  • 8-10 years in Quality Assurance in the pharmaceutical industry with stronge experience in a manufacturing / packaging cGMP environment.
  • Extensive experience in deviation / CAPA management, regulatory environments, cGMP, and FDA compliance.
  • What Your Role Will Look Like :

    The Senior Deviation Specialist will guide the Deviations team in managing investigations, implementing corrective actions, and maintaining compliancd with cGMP and FDA standards. This role involves collaboration across departments to address root causes, improve processes, and ensure regulatory compliance while mentoring team members and supporting continuous improvement initiatives.

    Investigation and Compliance :

  • Author and review deviation investigations for accuracy and clarity; ensure immediate actions are documented.
  • Assess and classify deviations based on risk; ensure interim controls are implemented.
  • Collaborate with SMEs to ensure timely deviation closure and review completed reports for thoroughness.
  • Initiate and track CAPAs to align with root causes.
  • Root Cause Analysis and Evidence Gathering :

  • Evaluate discrepancies related to various factors using root cause analysis.
  • Collect and organize evidence, including documentation and interviews.
  • Reporting and Trend Analysis :

  • Enter results into Track Wise; present reports clearly and comprehensively.
  • Identify and communicate quality trends to management.
  • Continuous Improvement and Metrics :

  • Identify and address quality trends, gaps, and risks.
  • Streamline processes to improve quality systems and organizational readiness.
  • Assist in tracking metrics and preparing reports related to deviations and CAPAs.
  • Cross-Functional Collaboration :

  • Partner with department leaders to build and inspection-readiness structure.
  • Implement improvements to quality processes and drive continuous improvement efforts.
  • About HTI

    Human Technologies, Inc. (HTI) has been a trusted partner since 1999, collaborating with leading companies to deliver tailored solutions for workforce management, development, and retention. HTI is an Equal Opportunity Employer M / D / F / V / SO.

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