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:
These are considered essential duties and are illustrative of those job tasks, which are fundamental. Work will take place in a warehouse environment. Employees may be required to perform additional related duties as may be assigned by management. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.
