ESSENTIAL JOB FUNCTIONS

• Ensure facility compliance with cGMP regulations (21 CFR Part 111 for dietary supplements, 21 CFR 210/211 for OTC drugs if applicable, and ISO 22716 for skin care).
• Maintain and oversee the Quality Management System (QMS), including SOPs, work instructions, and quality manuals.
• Manage regulatory inspections (FDA, state, third-party audits) and coordinate responses to findings.
• Stay updated on relevant regulatory changes and ensure facility compliance.
• Review and approve Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) for accuracy and compliance.
• Oversee and approve in-process checks (pH, viscosity, microbial limits, fill weights).
• Ensure that line clearance and changeover procedures are properly executed.
• Supervise incoming raw material testing (identity, potency, microbiological, heavy metals if applicable).
• Oversee finished product testing to ensure products meet specifications.
• Review and approve Certificates of Analysis (CoA) from third-party labs.
• Approve and maintain the Approved Supplier Program.
• Conduct supplier qualifications, audits, and periodic reviews.
• Ensure proper raw material traceability and adherence to quality specifications.
• Investigate deviations, non-conformances, and customer complaints.
• Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
• Manage change control for processes, materials, and equipment affecting product quality.
• Train staff on cGMP, SOPs, hygiene, and quality standards.
• Maintain training records and ensure ongoing competency of production and quality teams.
• Ensure proper documentation practices (GDP).
• Maintain and archive all quality records, batch documentation, and testing results per regulatory requirements.
• Monitor and ensure compliance with sanitation and cleaning validation protocols.
• Oversee environmental monitoring for microbial contamination (particularly for liquid products).
• Make final product disposition decisions (release, reject, or hold).
• Participate in product recall investigations and ensure recall procedures are in place.
• Identify process improvements to enhance product quality, efficiency, and compliance.
• Participate in cross-functional meetings to ensure quality considerations are integrated into production planning.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

• Knowledge of Excel, Word, and Adobe software.
• Communication and management skills.
• Ability to manage, carryout, and prioritize departmental functions.
• Ability to see areas that need improvement and to address them.
• Extensive background in quality systems and food and beverage manufacture.

MINIMUM QUALIFICATIONS

• 10 years’ experience in quality operations in the food and beverage sector.
• 5 years’ experience of management in the quality operations of the food and beverage sector and preferably dietary supplements.
• 4-Year degree in Food Science or equivalent field.
• Driven, organized, and detail orientated individual.
• Excellent communication skills.

The Quality Operations manager leads both the Quality Assurance and the Quality Control Departments. He/she is responsible for facility wide adherence to FDA Guidelines (including DSHEA and cGMP practices). In addition, the Quality Ops Manager must manage all QC lab functions to guarantee compliance of finished product to customer and industry standards. He/she is responsible for the management and maintenance of quality system and regulatory programs. This person must also manage customer complaints, quality improvement initiatives, and corrective actions programs.