COMPLIANCE SPECIALIST (Deviations & Investigations)

United Pharma; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Deviation investigations

CAPA investigations

Project management

Quality Management System

Regulatory knowledge

Leadership/mentoring

Education

Bachelor's degree in life sciences or chemistry

Tools

TrackWise

Veeva Vault QMS

MasterControl

Job description

This role is for a Compliance Specialist who will conduct deviation and discrepancy investigations, lead root cause analysis, and implement and monitor CAPA within GMP pharmaceutical/biotech operations, while supporting clients’ compliance programs and audits.

Responsibilities

• Conduct and document formal investigations on assigned deviations or discrepancies by following client’s procedures. Ensure investigations are completed and documented in accordance with client’s procedures.
• Uses the client’s Quality Management System (QMS) [such as TrackWise, Veeva Vault QMS or Master Control to complete the investigations and process the deviations.
• Adhere to the required industry regulations and standards and data integrity (cGMP, ICH, CFR, ALCOA++)
• Lead Root Cause Analysis (RCA) by assembling key personnel and applying RCA tools such as 5 Whys, Fishbone (6M), FMEA, DMAIC and others.
• Determine appropriate and effective Corrective Action and Preventative Action (CAPA) plan with key personnel.
• Implement CAPA and monitor effectiveness and trends. Implementation of CAPA must follow client’s change management program.
• Provide remediation actions for noncompliance situations and develop realistic plans to overcome them.
• Provide guidance to junior specialists and engineers.
• Coordinate meetings with cross-functional departments, to drive compliance project progress, facilitate decisions, provide updates.
• Other duties as assigned by client, and/or employer, based on workload, project requirements, and business needs.

Qualifications

• Degree requirement: Bachelor’s degree in life sciences, chemistry, etc…
• 5+ years of experience with Deviation and/or CAPA investigations, and project management with cross functional teams in the pharma/biotech industry.
• 5+ years of experience in the pharmaceutical industry, with knowledge of requirements for GMP operation.
• Strong 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 (key for sterile work), and ICH Q9/Q1
• Extensive knowledge of industry regulations and governing laws (US, EU).
• Experience with conducting audits to determine level of compliance and identify risks.
• Strong technical writing skills.
• Leadership skills to manage communication and provide mentorship.
• Certification in regulatory and compliance assurance would be an asset.