Quality Supervisor

Martin Marietta•Waynesville, NC

13d•Onsite

About The Position

The Quality Supervisor is responsible for managing a team of Quality Associates who support repackaging operations across multiple shifts. This role ensures adherence to good documentation practices and compliance with applicable procedures for both Operations and Support personnel. The supervisor will maintain a regular presence in repackaging operations to monitor GMP programs and quality systems, and ensure the team is adequately trained in compliance with applicable regulations. Key responsibilities include oversight of batch record review, troubleshooting documentation issues, and assessing, creating, and triaging deviations and observations from routine operations and audits. The role also involves reviewing and approving GMP documentation such as quality holds, COQ records, returns, and complaints, participating in inspections, and working collaboratively across the organization. A critical function is ensuring the follow-up and completion of Quality Event investigations, including CAPA, OOS, Non-Conformances, Deviations, SCARs, and Customer Complaints.

Requirements

High School Diploma or equivalent
5+ years experience in quality leader role supporting repackaging, final packaging, or manufacturing operations

Nice To Haves

Bachelor’s degree
Experience in repackaging or finished goods production.
Knowledge of ISO/ FDA/ CFR regulations and guidance.
Strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Demonstrated knowledge and understanding of manufacturing processes, batch record review, quality systems, and cGMPs
Familiarity and working proficiency with inventory management systems and Quality Management Systems (eg., SAP, XA, MasterControl, Trackwise, Veeva, etc.)
Strong attention to detail
Proven ability to work independently as well as team integration to resolve issues.

Responsibilities

Managing a team of Quality Associates supporting repackaging operations across multiple shifts.
Ensuring adherence and understanding of good documentation practices and compliance with applicable procedures.
Maintaining regular presence in repackaging operations to monitor GMP programs and quality systems.
Ensuring team is trained and training is in compliance with applicable regulations.
Oversight of batch record review and documentation troubleshooting.
Assessing, creating, and triaging deviations/observations from routine repacking operations and audits.
Reviewing and approving GMP documentation (quality holds, COQ records, returns, customer complaints, supplier complaints).
Participating in self-led inspections and providing support during internal/external regulatory inspections.
Working cross-functionally and collaboratively with all levels of the organization.
Ensuring follow-up and completion of Quality Event investigations (CAPA, OOS, Non-Conformances, Deviations, SCARs, Customer Complaints).