Lead Investigator

Pfizer • Sanford, NC

395d • $78,000 - $130,000

About The Position

The Lead Investigator role at Pfizer is focused on investigating quality issues in manufacturing and quality laboratories. The position involves analyzing deviations, out-of-specification results, and atypical investigations to ensure compliance with regulatory requirements and company policies. The Lead Investigator will utilize problem-solving skills to identify root causes and propose corrective action plans, contributing to the overall quality assurance and control processes within the organization.

Requirements

• High School Diploma (or Equivalent) with 8 years of relevant experience, or an Associate's degree with 6 years of experience, or a Bachelor's with at least 3 years of experience, or a Master's with more than 1 year of experience.
• Experience in technical writing.
• Time management and organizational skills.
• Proven record of problem-solving and decision-making skills.
• Background and knowledge in manufacturing, compliance, and technology investigations.
• Effective communication skills, both written and verbal.
• Computer literate.

Nice To Haves

• Knowledge and experience in Six Sigma and Lean methodologies.
• Relevant experience with cGMP in a biopharmaceutical or pharmaceutical environment.
• Experience with completing investigations within a quality tracking system (QTS/eQMS).
• Experience with FDA and EU licensing and inspection.
• Experience with project management.
• Experience using Documentum systems, laboratory information management systems, learning management systems, inventory management systems, and asset management systems.

Responsibilities

• Complete investigations in the site investigations electronic system as part of the GTx/mAbs Investigations team.
• Coordinate CAPA and drive timely closure of investigations.
• Perform investigations for manufacturing-related deviations using DMAIC tools for root cause analysis.
• Interact and coordinate with internal departments, outside vendors, and regulatory bodies during investigations.
• Facilitate cross-functional and cross-site team meetings for thorough investigations.
• Identify root causes, present complex problems, and lead resolution efforts.
• Assess the impact of events on products, equipment, or processes.
• Communicate discrepancies that may impact product disposition or shipments to management.
• Propose solutions to identified problems and determine corrective actions and continuous improvements.
• Track, trend, and evaluate previous events and assess CAPA effectiveness.
• Draft investigation reports with clear and concise summaries and product impact assessments.
• Collaborate with QA to close investigations and assign responsibility for CAPA commitments.
• Support regulatory and internal audits by discussing and defending previous investigations.
• Manage multiple initiatives simultaneously and provide updates on investigation status.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED