Quality Assurance Analyst, Sr. - Healthcare jobs in Minnesota

Plan, coordinate, and direct facility Quality Assurance and Food Safety Programs in compliance with all DFA policies, procedures, customer specifications, and regulatory requirements. Work collaboratively with the plant management team to improve overall plant performance. Support and implement a culture of quality. Inspire employees to greater levels of professionalism, quality, productivity, and engagement with the DFA team.

• Ensure daily plant Quality and Food Safety operations are in compliance with DFA policies, procedures, customer requirements, and local, state, and federal regulations
• Ensure escalation of non-conformance events to the proper operations and corporate QA personnel
• Maintain robust and effective Food Safety and Quality Plans with supporting prerequisite programs. Collaborate with plant and corporate resources to ensure the plant is always at a regulatory state of readiness for all applicable food safety regulations. Monitor and make recommendations for improvement
• Lead customer specification management

• Participate in the review of new and revised versions of specifications
• Ensure that the plant has the capabilities to meet the customer specifications
• Ensure SAP is aligned to report tests results and required information correctly on the certificate of analysis (COA's)
• Monitor compliance to customer specifications and communicate any issues/concerns

• Manage "Hold and Release" programs for finished products and ingredients
• Manage standardized operating procedures (SOP's)

• Ensure plant personnel have access to the most recent versions of the Corporate Standardized SOP's and that all training records are current
• Maintain a matrix chart by job description at the plant which indicates which SOP's are applicable by job description
• Prepare plant specific versions of SOP's as directed by the Corporate SOP or as needed for the plant
• Ensure all forms and work instructions are linked to the plant SOP's and are reviewed, revised, and updated annually

• Provide ultimate oversight of the plant laboratory operations (staff, training, compliance to the DFA Laboratory Quality Manual and Methods) for both the fluid and finished product laboratories

• Oversee auditing

• Facilitate internal, customer, corporate, and regulatory audit visits
• Actively participate in plant internal audits. Ensure plant walkthroughs are completed at a routine frequency to ensure compliance to programs.
• Engage cross-functional teams as required to ensure audit response reports are completed in the allotted time frame and sustainable corrective actions are identified, agreed to, and implemented within defined time lines

• Manage CAPA systems (Corrective Action/Preventive Actions)

• Manage all Quality and Food Safety CAPAs. Oversee team assignments to ensure proper root cause analysis and implementation of corrections and verification of effective/sustainable actions

• Manage customer/consumer complaints

• Manage the plant investigation for all complaints. Ensure timely response and a thorough review of all records and retains. Provide written reports to corporate QA Director

• Maintain quality/food safety related certifications and licenses at the site
• Implement and oversee Pathogen Environmental Monitoring Program

• Ensure the programs are being followed, all corrective actions are completed, and all records are current

• Conduct investigations into incidents and quality issues. Document findings, perform trend analysis, and communicate to management, employees, and customers as appropriate
• Monitor needs for capital and expense dollars in support of Quality and Food Safety goals. Work collaboratively with the plant manager to make preventative suggestions

• Oversee record review

• Provide ultimate oversight to ensure all records are completed as required and review/approval is current for laboratory, sanitation, and production documents. Assess product quality, ensure products meet DFA and/or customer specifications, and approve products for release to customers

• Manage human resources activities for team

• Convey company, facility, and department goals to employees
• Work with employees to formulate goals, monitor progress, and support growth plans

• Set clear expectations for direct reports. Hold team meetings to allow for clear communication of objectives and shared thoughts from co-workers
• Facilitate scheduling and/or delivery of quality/food safety training to meet corporate and regulatory requirements. Complete training as required to maintain license and certifications required by the position. Ensure training effectiveness and comprehension

• Measure continuous improvement

• Track and report on plant quality Key Performance Indicators (KPIs)
• Participate in measurement of the Cost of Non-Conformance

• Manage sanitation programs

• Ensure all SSOP's and associated forms are current and the programs are being followed
• Participate in monthly meetings with the plant sanitarian and sanitation service provider
• Ensure all corrective actions from service reports are implemented and documented
• Ensure all CIP verifications and validations are complete each year
• Ensure all variances noted on chart recorders are reviewed and appropriately responded to

• Manage pest control programs

• Ensure the plant programs are current and being followed
• Provide oversight and guidance to the plant sanitarian in regards to supervision of the program
• Review the monthly plant service reports and ensure corrections and corrective actions are being implemented and documented
• Ensure pest trends are monitored and action plans are implemented

• Maintain current knowledge through seminars and industry publications to develop skills and improve job performance. Attend required training, including but not limited to Safety, GMP, HACCP, FSMA and Safe Quality Foods (SQF)
• Ensure availability to respond to emergencies or other unexpected operational requirements (i.e., nights, weekends, or holidays). Participate in on-call rotation as needed
• Participate in the annual plant budgeting process
• The requirements herein are intended to describe the general nature and level of work performed by employee, but is not a complete list of responsibilities, duties, and skills required.Other duties may be assigned as required.

• Bachelor's degree
• 5 years of experience in food processing environment
• Minimum of 3 years supervisory/management experience
• Excellent Communication and presentation skills to all level of the organization
• Computer Skill- proficient use of Microsoft Suite
• Valid Driver's License
• Must be able to read, write and speak English
• PQCI Certification or obtain within first 90 days
• Completed Better Process Control School or obtain within first 90 days

Preferred Requirements:

• Degree in Food Science, Biological Sciences or related field
• Experience in dairy manufacturing
• SQF Practitioner certified or obtain within first 90 days
• HACCP certification or obtain within first 90 days
• LACF experience

An Equal Opportunity Employer