GMP Compliance Investigator: Deviations & CAPA Lead

United Pharma; Illinois; Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

United Pharma is seeking a Compliance Specialist to drive deviation investigations, root cause analysis, and CAPA implementation within GMP pharma/biotech operations. You will support audits and client compliance programs while mentoring junior staff.

The role requires strong QMS experience, knowledge of 21 CFR and EU GMP, and the ability to coordinate cross-functional teams to ensure timely remediation and continuous improvement.

Formación

• Bachelor's degree in life sciences, chemistry, or a related field.
• 5+ years of experience with deviation and/or CAPA investigations and project management with cross-functional teams in pharma/biotech.
• 5+ years of experience in the pharmaceutical industry with knowledge of GMP requirements.
• Hands-on experience with a Quality Management System.
• Experience in sterile or aseptic manufacturing is a major asset.
• Working knowledge of 21 CFR 210/211, 21 CFR Part 11, EU GMP Annex 1, and ICH Q9/Q1.
• Extensive knowledge of US and EU industry regulations and governing laws.
• Experience conducting audits to determine compliance and risks.
• Strong technical writing skills.
• Leadership to mentor and guide teammates.
• Regulatory/compliance certification would be beneficial.

Responsabilidades

• Conduct and document investigations on deviations or discrepancies following client procedures.
• Use client QMS (TrackWise, Veeva Vault QMS or MasterControl) to complete investigations and process deviations.
• Adhere to cGMP, ICH, CFR, and ALCOA++ data integrity standards.
• Lead Root Cause Analysis using RCA tools (5 Whys, Fishbone, FMEA, DMAIC).
• Develop and implement effective CAPA plans with stakeholders.
• Implement CAPA and monitor effectiveness per change-management processes.
• Provide remediation actions and realistic plans for noncompliance.
• Guide junior specialists and engineers through processes and findings.
• Coordinate cross-functional meetings to drive progress and decisions.

Conocimientos

Deviation investigations

CAPA investigations

Project management

Quality Management System

Regulatory knowledge

Leadership/mentoring

Educación

Bachelor's degree in life sciences or chemistry

Herramientas

TrackWise

Veeva Vault QMS

MasterControl

Descripción del empleo

United Pharma is seeking a Compliance Specialist to drive deviation investigations, root cause analysis, and CAPA implementation within GMP pharma/biotech operations. You will support audits and client compliance programs while mentoring junior staff.

The role requires strong QMS experience, knowledge of 21 CFR and EU GMP, and the ability to coordinate cross-functional teams to ensure timely remediation and continuous improvement.