Pharmaceutical - COMPLIANCE SPECIALIST (Deviations & Investigations)

MMR Consulting • Chicago, CO

2d • $95,000 - $130,000 • Onsite

About The Position

MMR Consulting is seeking a Compliance Specialist to join their growing team. This role involves working onsite at client facilities in Kankakee, IL, US, to investigate deviations or discrepancies, analyze root causes, and implement Corrective and Preventative Actions (CAPA). The specialist will support clients' compliance programs and audits within GMP pharmaceutical/biotech operations. This is an outstanding opportunity to work with a group of engineers and specialists in the pharmaceutical/biotechnology and highly regulated industries.

Requirements

• Previous Pharmaceutical/Biotech experience is mandatory.
• 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.
• 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.
• Ability to lift 50 lbs.

Nice To Haves

• Experience in sterile or aseptic manufacturing is a major asset.
• Certification in regulatory and compliance assurance would be an asset.

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.
• Use 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.

Benefits

• As part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.
• Equal Employment Opportunity and Reasonable Accommodations
• MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
• Our hiring decisions are based on merit, qualifications, and business needs.
• We are committed to working with and providing reasonable accommodations to individuals with disabilities globally.
• If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level