GMP Compliance & CAPA Specialist — Pharma/Biotech

MMR Consulting; Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Job summary

MMR Consulting is seeking a Compliance Specialist to join our engineering and consulting team onsite at client facilities in Kankakee, IL. You will investigate deviations, lead root-cause analyses, and implement CAPAs within GMP pharma/biotech operations while supporting client compliance programs and audits.

Responsibilities include documenting investigations, leading RCA, and coordinating cross-functional teams to ensure CAPA effectiveness and regulatory compliance.

Qualifications

• Bachelor’s degree in life sciences or chemistry.
• 5+ years of deviation and/or CAPA investigations with cross-functional teams in pharma/biotech.
• 5+ years of pharmaceutical industry experience with GMP operations.
• Strong hands-on experience with a Quality Management System (QMS).
• Experience in sterile or aseptic manufacturing is a major asset.
• Knowledge of 21 CFR 210/211, 21 CFR Part 11, EU GMP Annex 1, ICH Q9/Q1.
• Extensive knowledge of US/EU regulations and laws.
• Strong technical writing and leadership abilities.

Responsibilities

• Conduct and document formal investigations on deviations or discrepancies following client procedures.
• Use client QMS tools to complete investigations and process deviations.
• Adhere to cgmp, ICH, CFR, and data integrity requirements (ALCOA++).
• Lead Root Cause Analysis (RCA) using RCA tools (5 Whys, Fishbone, FMEA, DMAIC).
• Develop and implement CAPA plans with key personnel.
• Monitor CAPA effectiveness and trends following change-management processes.
• Provide remediation actions for noncompliance and develop realistic improvement plans.
• Guide junior specialists and engineers.
• Coordinate cross-functional meetings to drive project progress and decisions.

Skills

Deviation investigations

CAPA investigations

Project management

QMS experience

Regulatory knowledge

Education

Bachelor's degree in life sciences

Tools

TrackWise

Veeva Vault QMS

Master Control

Job description

MMR Consulting is seeking a Compliance Specialist to join our engineering and consulting team onsite at client facilities in Kankakee, IL. You will investigate deviations, lead root-cause analyses, and implement CAPAs within GMP pharma/biotech operations while supporting client compliance programs and audits.

Responsibilities include documenting investigations, leading RCA, and coordinating cross-functional teams to ensure CAPA effectiveness and regulatory compliance.