DEVIATION SPECIALIST
: Job Details :

HTI is seeking a Deviation Analyst 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:

• Bachelors degree preferred, or an associate degree with relevant experience in the pharmaceutical industry
• 2+ years of experience in a manufacturing/packaging cGMP environment

What Your Role Will Look Like:

The Deviation Specialist thoroughly investigates deviations that arise in various aspects of the company, including Manufacturing, Quality Control, and Facilities, using problem-solving tools such as root cause analysis to assist with identification of appropriate corrective actions to prevent recurrence. Collaborates with various departments to gather information, evaluate causal factors, and implement appropriate CAPAs, based on root causes identified in deviation. Ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to deviation investigations, deviation initiation, and related CAPAs. Facilitates cross-functional meetings and provides guidance and consultation to the deviation/CAPA process owners and makes recommendations to continuously improve processes.

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.

Skills and Abilities:

• Strong communication skills with the ability to present complex information clearly.
• Analytical and problem-solving skills with attention to detail and effective prioritization.
• Understanding of cGMPs and FDA regulations; ability to work independently and adapt quickly.

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.