Pharmaceutical - COMPLIANCE SPECIALIST (Deviations & Investigations)

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

Job summary

MMR Consulting in Round Lake, IL, is seeking a Compliance Specialist to conduct deviation investigations, lead root cause analysis, and implement CAPA within GMP pharmaceutical/biotech operations at client facilities.

You will support compliance programs and audits, mentor junior staff, and coordinate cross-functional teams to drive timely issue resolution and remediation. Travel to client sites may be required.

Qualifications

• 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.

Responsibilities

• Conduct and document formal investigations on assigned deviations or discrepancies by following client’s procedures.
• Uses the client’s Quality Management System (QMS) 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 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.

Skills

Deviation investigations

CAPA management

Root cause analysis

Quality management system

Leadership

Technical writing

Mentorship

Regulatory knowledge

Travel readiness

Data integrity

Cross-functional coordination

GMP knowledge

Education

Bachelor’s degree in life sciences

Tools

TrackWise

Veeva Vault QMS

MasterControl

Job description

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical /biotechnology and highly regulated industries. Its services include Engineering, Project Management, and Validation.

MMR Consulting has offices across North America and Asia.

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 Round LakeIL , 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

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.