Nutracap Labs is seeking a Quality Control Manager who will report to the Chief Operations Officer.
Reporting to the Chief Operations Officer, the Quality Control Manager's duties include, but are not limited to:
- Initiate, establish, and manage Quality Control and Quality Assurance standards and processes for the manufacturing of dietary supplements in compliance with cGMP (21 CFR part 111), including the implementation of improved quality reporting measures, raw material analysis and testing.
- Closely monitor production issues and execute processes to rule out potential problems with dietary supplements products.
- Ensure good trackability and traceability of incoming and outgoing materials or products.
- Work with suppliers to ensure quality, accuracy, and proper documentation of all dietary supplement ingredients.
- Support management in ensuring compliance of all lab activities including the organization of materials, stock levels, workflows, and testing per cGMP (Current Good Manufacturing Practices) SOPs (Standard Operating Procedures).
- Work with customers and third party testing partners to provide the necessary documentation per cGMP (COAs, testing, and related documentation).
- Support management and customers in the establishment of expiration dates of dietary supplements using analysis of available stability data and analyses.
- Perform training for Nutracap employees in all aspects of Quality Management Systems.
- Support quality related customer complaint investigations and trending activities relating to dietary supplements manufactured at the lab.
- Manage inventory of manufactured products and retain samples and carry out annual product reviews.
- Investigate any quality issues in production and take steps towards corrective and preventive action (CAPA).
- Lead cGMP and Organic certification efforts and renewals.
- Lead Internal Audits and help Nutracap prepare for external audits.
- Monitor manufacturing at every stage of production and giving final authorization to releasing high standard quality products from the lab facility.
- Create, review and approve product (dietary supplements) master formulas and manufacturing procedures, product standards and specifications, quality standards, packaging specifications and regulatory documentation.
- Direct workers engaged in inspection and testing activities or Nutracap’s products to ensure continuous quality control over materials, facilities, and products.
- Ensure the maintenance of regulatory databases, archives, and document management system.
- Review of batch records and ensure that the documentation that supports Nutracap’s products are made with compliance to SOPs and related processes and procedures.
- Ensure that company product related policies and procedures are current and compliant with regulatory agency guidelines, including USFDA, USDA, and where applicable, and international regulatory agencies per current business plans.
- Present Quality Assurance considerations in management decision-making process to ensure the manufacture of safe, potent, pure, and compliant products.
- Lead root cause investigations of product failures and issues using First Principal Logic.
Master’s Degree in Food Science and Technology + 2 years’ experience in the job or
Head of Quality or Quality Manager or closely related, including experience in quality assurance of custom dietary supplements manufacturing.
JOB TYPE: Full-time. On-site. 8:30 AM - 5:00 PM EST, Mon - Fri.
Hand sanitizer provided, gloves and mask upon request
- Corrective And Preventive Action (Capa)
- Decision Making
- Document Management Systems
- Good Manufacturing Practices