Previous Pharmaceutical/Biotech experience is mandatory for this role.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists to help our clients investigate deviations or discrepancies, analyze for root cause and implement sound Corrective Action and Preventative Action. The work will require working onsite out of the client's facilities in the Kankakee, IL , US.
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.
- Ability to lift 50 lbs.
- Travel may be required on occasion.
Compensation: $95,000 to $130,000
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.
