HTI is seeking a 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 preferred, or an associate degree with relevant experience in the pharmaceutical industry
- 2+ years of experience in a manufacturing/packaging cGMP environment
- Understanding of cGMP and FDA regulations.
- Experience with TrackWise Quality Management System preferred.
What Your Role Will Look Like:The Deviation Specialist is responsible for investigation deviations, identifying root causes, and implementing corrective and preventative actions to maintain complaince with regulatory standrads.This role collaborates with cross-functional teams to drive quality improvements, track trends, and ensure timely resolution of issues. Investigation and Compliance:
- Conduct thorough investigations of deviations using TrackWise, ensuring accuracy and clarity in reports.
- Assess deviations for risk and perform initial quality impact assessments.
- Identify and implement interim control measures to address deviant conditions.
- Collaborate with Subject Matter Experts to ensure timely closure of deviations and initiate extension requests when necessary.
- Approve completed investigation reports and ensure CAPAs align with root causes.
Root Cause Analysis and Evidence Gathering:
- Use root cause analysis tools to address discrepancies in materials, processes, equipment, or personnel.
- Collect and organize evidence, including documentation, interviews, and video footage, ensuring all supporting materials are legible and properly identified.
- Present findings in a clear, logical, and comprehensive manner.
Reporting and Quality Trends:
- Enter investigation results into TrackWise and maintain concise, sequential documentaation.
- Analyze and report quality trends to management.
About HTIHuman 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.INDPRO