Quality Supervisor

Essential Duties and Responsibilities

• Responsible for managing a team of Quality Associates who support repackaging operations across multiple shifts.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
• Ensures regular presence in repackaging operations to monitor GMP programs and quality systems.
• Responsible for ensuring team is trained, and training is in compliance with applicable regulations.
• Oversight of batch record review and documentation troubleshooting.
• Ability to assess, create, and triage deviations/observations that occur during routine repacking operations and from internal and external audits.
• Reviews and approves GMP documentation in support of daily operations such as: quality holds, cost of quality (COQ) records, returns, customer complaints, supplier complaints, and other documentation, as required.
• Participates in self-led inspections and provides support during internal/external regulatory inspections.
• Works cross-functionally and collaboratively with all levels of the organization.
• Ensure follow-up and completion of Quality Event investigations including: CAPA, OOS, Non-Conformances, Deviations, SCARs and Customer Complaints.

Basic Requirements

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

Additional Skills/Preferences

• 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.

Additional Information

• Position is first shift, but second or third shift work may occasionally be required.
• May be required to respond to operational issues outside of scheduled business hours.

Work Environment / Conditions / Physical Demands

• Work will take place in a warehouse environment.
• Work will take place in various types of manufacturing environments as well as in outdoor settings.
• Prolonged standing, climbing, pulling and lifting of heavy objects may be included in the job tasks.
• The Quality Supervisor is responsible for adhering to safety rules and maintaining a safe work environment for themselves and others.