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Quality Assurance Manager
2 months ago
This position is responsible for ensuring compliance with product safety and quality elements related to manufacturing operations. The successful candidate will be responsible for managing and upholding quality in all operational processes, as defined by 21 CFR 111.
Key Responsibilities- Ensure compliance with corporate quality programs, handle audits, and lead/implement sustainable improvements.
- Manage, oversee, and maintain quality in all operational processes, including cGMP, audit, international compliance initiatives, training, document control, deviation, root cause analysis, and CAPA.
- Coordinate with operations site leadership to drive improvements, focusing on prevention vs. detection of defects and coordinating actions to prevent nonconformities.
- Responsible for performance evaluation, coaching, counseling, and preparing corrective action for employees, and liaising with HR and other support functions.
- Shared responsibility with Production Manager for sanitation program, including sanitation procedures, housekeeping, and pest control procedures.
- Bachelor's degree in a related field or equivalent experience.
- Minimum 5 years of experience in a regulated industry, with a focus on quality assurance and compliance.
- Minimum 2 years of supervisory experience.
- Experience with HACCP/HARPC, FSVP, NSF, GFSI, FDA, USDA Organic, SPC, and other relevant quality assurance standards.
- High sense of accountability and self-driven approach.
- Strong project management and continuous improvement mindset.
- Ability to motivate and influence people positively, with strong risk assessment, organizing, planning, and problem-solving skills.
- Effective interpersonal and communication skills, with the ability to manage time effectively.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Occasional lifting of 0 to 25 lbs.
Reports toSr. Director Quality
Company OverviewDesigns for Health is an industry-leading manufacturer and distributor of nutritional supplements, dedicated to providing comprehensive support to healthcare practitioners and their patients. Our mission is to design a well world, together.
