Temporary Compliance Supervisor

Advatix, Inc.•Detroit, MI
•Remote

About The Position

The Compliance Supervisor is responsible for managing, implementing, and overseeing the ISO Quality Management System and Good Manufacturing Practices (GMP) compliance activities to ensure continued conformance to documented standards. The role oversees quality-system implementation and maintenance, internal audits and corrective actions, training, management reviews, and support for internal and client compliance requirements. The position is offered as temporary and may be performed remotely from Toronto, Ontario, or 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.
  • Minimum of 3 years of work experience in a quality and/or compliance management position.
  • ISO quality and GMP compliance experience.
  • Problem-solving ability, including collecting and analyzing data to foster 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 for operations 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 activities 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 and data collection and adherence to ongoing compliance initiatives.
  • Monitor changes to governing standards and identify internal changes required to support those 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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