Intiva Health Quality Assurance Manager in Tempe, Arizona
The Quality Assurance (QA) Manager is responsible for overseeing quality activities regarding the safety, consistency, and quality of our products, This includes developing, implementing and maintaining quality programs, policies and procedures to improve product quality and ensure products are produced in compliance with product standards, good manufacturing practices and in accordance with government regulations. In addition, this role will be required to interact with both internal and external customers, as well as quality and regulatory agencies and manage a staff of both quality assurance and quality control technicians. The individual in this position must establish and maintain relationships with direct reports in addition to other departments in the organization to effectively cultivate a culture of continuous improvement in which quality, safety, and productivity goals are measured and met.
Essential Duties and Responsibilities:
Responsible for all aspects of company Quality Assurance and Regulatory affairs in compliance with local, state, and federal food safety standards at our dietary supplement manufacturing facility.
Develops, implements, monitors, and continuously improves programs to ensure compliance with industry standards for food and dietary supplements (cGMP, GLP, CFR 100, CFR 111, HACCP, FSMA, SQF, etc.)
Leads internal, external customer & other regulatory agency audits & escalates any quality control and food safety issues and presents plausible solutions
Works with R&D and Manufacturing departments in the development, scale-up, and testing of new products, processes, and equipment
Produce release documentation for each lot of finished product
Perform and monitor shelf-life studies.
Develop statistically significant sampling plans for incoming raw ingredients and in-process quality checks to insure food safety and quality.
Oversee and develop the corporate Facility Audit Program to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives.
Conduct training and re-certification as appropriate for quality and other manufacturing personnel
Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ?culture of quality?.
Ensures timely resolution to customer inquiries (audit findings and complaints)
Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
Oversee Document Control and lead Change Control (formulas, raw materials, and packaging materials) systems.
Responsible for Raw Materials Supplier Qualification activities including the supplier audit program.
Organize and ensure the completion of all product investigations, Non-Conformances, OOS?s, and CAPAs, including documenting and reporting adverse and serious adverse events.
Prepare periodic reports, quality scorecards and analyses to executive management.
Direct and oversee the work of quality assurance and quality control technicians, including training, mentoring, and ensuring professional development.
Experience with quality assurance software that allows integration of product development, quality control (testing specs), quality assurance, project management, purchasing, as external vendors.
Develop and maintain a product testing lab for all composition and microbial testing of all raw ingredients and finished products.
Responsible for regulatory compliance of NFP?s, SFP?s and other product label claims
Perform other duties as assigned depending upon business needs
Additional Skills & Competencies:
Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
Manages competing demands, makes timely and sound decisions, even under conditions of risk.
Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.
Effectively influences actions and opinions of others.
Ability to perform effectively and efficiently in a fast-paced environment.
Excellent organizational and interpersonal skills.
Ability to work within a team environment, as well as independently, with minimal supervision.
Maintains high level of confidentiality.
BS degree in Food Science, Microbiology, Chemistry, Engineering or related field of study
Minimum of five years? experience working in a Quality function at a food or dietary supplement manufacturing facility
2+ years in a leadership role
Preferred Knowledge, Skills and Abilities:
Must be flexible and willing to work the demands of the department which may be subject to evenings, weekends and holidays.
Solid understanding of manufacturing processes, process development, and troubleshooting.
Strong interpersonal skills, detail oriented and able to coordinate/manage multiple tasks simultaneously.
Must be a non-tobacco user and will not use tobacco products on or off the job during the tenure of employment in Quality Assurance, as it may affect taste accuracy testing.
No dietary restrictions or food allergies.
10+ year experience working in a similar role at a dietary supplement manufacturing facility
5+ years in a leadership role
Experience in Six Sigma, Lean or equivalent.
Statistical design and process control measurement and analysis
ASQ Certifications (CQE, CQA etc.), knowledge of FSMA, SQF regulations.
PCQI, HACCP Trained, and SQF Practitioner
- Required; MS Word, Excel, Outlook, ERP, quality management software