What are the responsibilities and job description for the Director Quality Assurance Quality Control position at Valensa International?
Valensa International is a leading innovator of pure, science-based, and clinically effective nutraceutical solutions proven to benefit health and wellness. For twenty years Valensa has partnered with nutraceutical, food, and pharmaceutical companies to bring condition-specific solutions for human and companion-animal well being to market.
Job Title: QA/QC Director
Job Summary
The QA/QC director will be responsible for overseeing the Quality Assurance and Quality Control activities within the Valensa manufacturing process. This role ensures that products meet all regulatory standards and are produced in accordance with GMP, internal policies, and customer specification. The QA/QC director will be committed to driving excellence in all aspects of quality assurance and control to exceed customer expectations. He/She will oversee Valensa's quality processes to ensure the delivery of high-quality products, giving Valensa a competitive advantage and contributing to the company's success, while maintaining the highest industry standards.
Essential Job Functions
• Responsible for the ongoing development, implementation, and improvement of the Quality Management System.
• Ensure compliance with regulatory, corporate, customer and 3rd party audit requirements.
• Implementation and management of the Environmental Monitoring program.
• Manage plant HACCP food safety program and associated prerequisite programs.
• Management and implementation of the Hold and Release program, Supplier Approval program, and Stability Program.
• Conduct internal auditing (GMP, Sanitation, Safety and Quality Systems), and review of the quality system and operational activities including record review within a seven working days’ time frame, or written justification for extended timeframe.
• Participate in external audits from clients and regulatory agencies.
• Reviews and updates standard operating procedures as needed.
• Help to determine specifications for all new products and maintain current specifications on existing food products.
• Maintain and achieve goals related to key process improvements, and continuous improvements.
• Manage the development and release of new processes, and processing equipment.
• Train or manage training of all employees on GMP, HACCP, Sanitation, OSHA, and Food Defense annually and upon hire.
• Help develop and maintain pest control, safety, and sanitation programs including Master Sanitation schedule. Supervises Plant Sanitarian.
• Responsible for managing customer quality and product documentation to support Valensa in winning and retaining customers.
• Investigate customer complaints by determining root cause and communicate corrective action to the customer.
• Help coordinate and maintain food certifications.
• Responsible for document control for all procedures and forms.
• Designated PCQI - Responsible for the development and application of risk-based preventive controls.
• Develops, maintains, and reanalyzes the facility Food Safety Plan.
• Validate preventive controls within 90 days of production, if applicable.
Minimum Requirements/Qualifications
• Bachelor’s Degree in a scientific discipline.
• Minimum of 5 years of experience in Quality Assurance or Quality control within the nutraceutical, pharmaceutical, or food industries.
• Strong knowledge of Good Manufacturing Practices (GMP), HACCP, and regulatory compliance for the nutraceutical or food industry.
• Possess HACCP training certification.
• As PCQI – completed training under a standardized curriculum recognized as adequate by FDA.
Abilities required
• Verbal, written, computer, and technical communication and presentation skills.
• Ability to work independently.
• Ability to prioritize, and schedule work to meet personal and organizational deadlines.
