Temporary Compliance Supervisor

Advatix, Inc.•Chicago, IL
•Remote

About The Position

The Compliance Supervisor manages, implements, and oversees the ISO Quality Management System and Good Manufacturing Practices compliance activities to ensure ongoing conformance with documented standards. The role supports continued ISO 9001 certification, maintains compliance processes and documentation, and works with process owners, internal teams, and clients to meet governing and client requirements. The position is temporary and can be performed remotely from Toronto, Ontario, or from Detroit, Maple Grove, South Bend, or Chicago in the United States.

Requirements

  • Post-secondary education, preferably with a quality or compliance focus, or equivalent work experience.
  • At least 3 years of work experience in a quality and/or compliance management position.
  • Experience with ISO quality and GMP compliance.
  • Problem-solving ability, including collecting and analyzing data to reach valid conclusions and decisions.
  • Strong PC skills.
  • Proven organizational, time-management, and attention-to-detail skills.
  • Ability to communicate effectively at all levels, internally and externally.
  • Ability to work independently and in teams.
  • Ability to handle stressful situations with tact and control.
  • Ability to work autonomously.

Responsibilities

  • Oversee and manage implementation and maintenance of the quality system process to ensure continued ISO 9001 certification.
  • Partner with process owners to support ISO/GMP policies, procedures, and maintenance of internal documents in accordance with governing standards.
  • Coordinate and manage facility internal audits, including completion and reporting of audit results.
  • Manage, report, and monitor the facility internal Corrective Action Process (CAN) to ensure issues are resolved and closed.
  • Provide, implement, and support internal training related to ISO requirements and GMP compliance.
  • Lead and support third-party audits, including ISO, FDA, client, and security audits, acting as the facility Management Representative.
  • Coordinate and manage the ISO Management Review process.
  • Support development of internal client requirements related to compliance activities.
  • Support facility client activities as requested by internal teams to validate process monitoring, data collection, and adherence to ongoing compliance initiatives.
  • Monitor changes to governing standards and identify internal changes required to meet requirements.
  • Work directly or indirectly with clients to support client requirements and adherence to facility implementation requirements.
  • Support development, implementation, and revision of company policies and procedures.
  • Maintain regular and punctual attendance.
  • Perform other internal duties and responsibilities as required.
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