QA Operations Manager (Manufacturing)

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Global Widget is a vertically integrated, next-generation consumer packaged goods (CPG) manufacturer of quality health and wellness products, focusing on gummy production. Our dedication to innovation lies within our mission to formulate, manufacture and distribute the industry’s most-trusted products for health-conscious consumers everywhere.

Position Summary/Objective

The Quality Assurance Operations Manager will be a key member of the Global Widget Quality Assurance team and be responsible for overseeing all quality assurance aspects of manufacturing operations, ensuring compliance with regulatory standards (like GMP) by reviewing batch records, conducting quality audits, managing change controls, investigating deviations, and collaborating with production teams to maintain high product quality throughout the manufacturing process; essentially acting as the quality guardian on the shop floor, ensuring all products meet the necessary quality standards before release to market.

Essential Functions

• Oversee the various functions of Quality Assurance which support manufacturing operations including batch record writing and reviewing, training, and oversight of manufacturing activities.
• Review and approve batch records, including manufacturing and testing documentation, to verify compliance with established procedures and specifications.
• Work collaboratively with manufacturing, supply chain, quality control, regulatory, and project management to ensure timely availability of products and product release.
• Collaborate with cross-functional teams (manufacturing, quality control, regulatory affairs) to address quality concerns and drive continuous improvement.
• Work with suppliers and internal stakeholders to eliminate quality and compliance concerns via root cause analysis and ensure a continuous improvement approach.
• Support audits both regulatory and third party.
• Lead a team of QA personnel, providing training, coaching, and performance feedback.
• Perform or coordinate the periodic review of relevant SOPs.
  
  

Qualifications

Required Education and Experience

• At least 5 years of experience in an FDA regulated field with a minimum of 3 years of quality assurance experience.
• A minimum of 2 years of personnel management experience is preferred.
• BS degree in science, technology, engineering or math
• Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to Dietary Supplements and Food products
• Self-starter with demonstrated ability to deliver high-quality results in a fast-paced environment
• Excellent written, verbal communication and presentation skills
• Accuracy and attention to detail
• Collaborate with cross-functional teams (manufacturing, quality control, regulatory affairs) to address quality concerns and drive continuous improvement.
• Proven staff leadership abilities in developing staff and functional integration into multi-disciplinary project teams.
• Bilingual (English/Spanish) preferred