Temporary Compliance Supervisor

Advatix, Inc.•South Bend, IN

23h•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 ongoing conformance to documented standards. The position supports facility operations by maintaining quality-system processes, coordinating audits and corrective actions, providing training, and helping ensure compliance with applicable standards and client requirements. The role works with process owners and internal teams to maintain policies, procedures, and controlled documents; leads or supports third-party audits; coordinates the ISO Management Review process; and monitors changes to governing standards. The position may work remotely from Toronto, Ontario, or Detroit, Maple Grove, South Bend, or Chicago in the United States. The hiring organization, rather than HRforGrowth, makes all employment decisions and sets the terms and conditions of employment.

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 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 for operations to support 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 the 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 the development, implementation, and revision of company policies and procedures.
Maintain regular and punctual attendance.
Perform other internal duties and responsibilities as required.