Pharmaceutical - COMPLIANCE SPECIALIST (Deviations & Investigations)

MMR Consulting•Chicago, IL

1d•Onsite

About The Position

MMR Consulting is seeking a Compliance Specialist to join their team, focusing on deviations and investigations within the pharmaceutical and biotechnology industries. The role involves working onsite at client facilities to investigate deviations, analyze root causes, and implement corrective and preventative actions (CAPA). The specialist will support clients' compliance programs and audits, ensuring adherence to industry regulations and standards.

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.

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.
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.