Quality Operations Manager

Description

 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.

Skills

Gmp, fda, audit, cgmp

Additional Skills & Qualifications

- 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.

Experience Level

Expert Level