QA Manager - CAPA

Business Title: QA Manager - CAPA

Location: Albert Lea, MN 56007

Job Type: Full-time

Note: Direct hire

Position Summary:

• The Quality Assurance Manager is a key member of the manufacturing site leadership team that provides leadership at the site for development, implementation and administration of the Quality assurance and quality control functions to ensure safety integrity and conformance with respect to regulatory, corporate, site, and customer requirements. This position will work in collaboration with the plant and THE CLIENT leadership to formulate and execute a strategic quality plan for the business. This position also integrates quality priorities into the operational excellence process.
• Responsible for managing CAPA program, including customer complaint, vendor complaint, holds and site audit nonconformance programs and root cause analysis thereof. Responsible for management of change control and portions of commercialization process. Provides leadership to develop and implement food safety, preventive controls and prerequisite programs (eg: HACCP/HARPC, Pest Control, Recall, Allergen, Sanitation, and environmental monitoring.)
• As a member of the plant leadership team, requires comprehensive understanding of the concepts and principles within their own functional area, and also requires basic knowledge of these elements in their relevant functional areas in order to participate in the resolution of issues that have an impact beyond the area or impact multiple areas.

Key Responsibilities:

• Maintaining customer quality satisfaction through the implementation and use of programs to control raw materials, in-process materials, production process, environmental conditions and finished products.
• Empowers and develops their team and cross functional teams. Performs evaluations and creates development and or training plans for team members and manages employee relations.
• Ensures compliance with applicable laws and regulations such as FDA, EPA, OSHA and other state and federal agencies. Ensures compliance with contracted third-party certifications such as GFSI, Kosher, Halal, RSPO or others as needed.
• Conducts or coordinates Customer, Vendor and/or third-party audits and regulatory inspections. Executes plans that drive operational excellence for the operation. Prepares and oversees customer site visits and audits.
• Interacts with other Quality Managers, and corporate leadership and ensures timely issue escalation. Leads quality team in commercial product onboarding and trial reviews, specification creation, formula and label reviews, inspection plans for raw materials, in process materials and finished materials.
• Manages departmental staffing, management commitment and review process, budget & expenses, and capital projects.

Secondary Responsibilities:

• Partnership with site leaders and cross functional partners for goal setting, decision-making alignment, and training and development needs
• Supports Supply Chain, Learning and Development, and Commercialization functions as needed

People:

• Responsible for development and performance of the site quality team and ensuring training programs are in place for cross functional teams.
• Builds strong cross functional relationships and demonstrates ability to effectively influence and execute site strategy
• Develops a culture that drives quality improvements and efficiently interfaces with operational excellence processes
• Communicate effectively with internal and external customers.
• Timely escalation and communication of food safety, quality, financial issues
• Effectively cascade goals using tools such as SMART goals. Aligns with teams on standard work.
• Motivates and builds team strength
• Makes determinations and decisions on performance and pay for team members.

Systems:

• Responsible for the effective application of site Product Safety, Product Quality and prerequisite systems. Ensures these systems effectively interface with change control and commercialization processes.
• Strong ability to root cause issues and eliminate the cause or implement engineering or systems improvements to enact robust prevention. Applies use of basic root cause tools.
• Responsible for execution of internal audit program and ensures systems are working to reduce risk, and that corrective actions are completed
• Drives priorities that have largest positive impact on key performance indicators and metrics including but not limited to; Inspection/Compliance performance, First Pass Quality, Complaints, Disposals, Inventory Health, Customer Responsiveness, CAPA closure and effectiveness, systems performance, environmental & sanitation performance.
• Ensures that response to customers, inspectors and auditors are professional, timely, and in scope.
• Collaborates with R&D, Production, and commercial teams in the development and preparation for production of new Products, Processes, and Equipment to support new product/customer launches. Ensures the process quantifies the probability of success and clearly communicates the risks and proposed mitigations as an outcome of first-time makes.
• Interfaces with operational excellence programs to maximize effectiveness
• Provide support and aid in preparation for customer visits and external audits

Knowledge & Experience:

• Operated in an FDA regulated environment, ideally food or dietary supplement
• Assess and mitigate food safety, regulatory, and cost risks.
• Apply sanitation principles effectively.
• Application of Statistical Process Control (SPC) for process evaluation and improvements.
• Effective project manager that knows how to prioritize and meet deadlines
• 5 years of functional leadership experience

Requirements:

• 5 years Quality Assurance experience
• Solid FDA, HACCP, SQF, and industry best practices experience
• Bachelor’s Degree
• Creates and maintains a Quality culture
• Industry experience-Food/Bev Mfg, Pharma, Medical Device