Overview

POSITION SUMMARY:

The Quality Assurance Manager is a member of the site leadership team responsible for ensuring products (Baby Formula) manufactured at the site are safe, wholesome and comply with all applicable , customer and regulatory requirements. They will support and coach the site team in developing and maintaining a culture of best in class Quality through their influence and coaching. The QM is responsible for supporting and optimizing site quality operations and practices through effective data analysis and decision making.

Knowledge of regulatory requirements for Food, Feed, Infant Formula as well as chemical manufacturing is desired. This individual will develop, analyze, and drive associated programs to ensure maximum production quality, compliance to the Quality Management System, and compliance with cGMP requirements while supporting the company’s mission

The Quality Manager is directly responsible for the implementation of quality systems and initiatives within the facilities. This position is responsible for the daily operations as they relate to the production, packaging, receipt, storage, and release of food products manufactured within the facility. The individual in this position must establish relationships with not only her/his direct reports but within all departments in the organization to effectively cultivate a culture in which safety, quality, and productivity goals are met.

 

ESSENTIAL FUNCTIONS:

  • Responsible for performing all job requirements in a safe manner using the proper PPE and being a proactive safety role model with co-workers
  • Responsible for correcting/reporting unsafe behaviors or equipment to ensure a safe working environment
  • Responsible for cleanliness within the work department
  • Perform/execute job duties keeping the company’s commitment to quality in mind, developing strategy and executing tactical plans to support the department’s mission, and by being a role model for GMP on the floor
  • Monitor, maintain and continuously improve all food safety activities. Enforce product safety plan while producing product.
  • Develop, implement, and maintain polices and processes that ensure product manufactured meets or exceeds quality expectations defined within the QMS, the specific product specifications, and applicable quality agreements
  • Manage the internal audit process to confirm compliance to the QMS, with the expectation of creating and maintaining a state of audit readiness for both the system and overall facility within all company locations
  • Create and manage relationships with 3rd Party laboratories, consultants, and services that can support company initiatives
  • Manage customer expectations and relations in the manufacturing of products
  • Establish and implement metrics for monitoring quality standards and departmental effectiveness
  • Primary contact for all regulatory audits (FDA) within all facilities; management of internal and external negotiation of all corrective actions associated with customer and 3rd party audits
  • Prepare reports, analyze data, and make recommendations for improving operations
  • Provide mentoring and solutions to challenges for direct reports
  • Lead the effort in harmonizing the quality activities in all facilities
  • Initiate and support continuous improvement and elimination of waste and variation in processes using established improvement processes
  • Must develop cooperative relationships with other departments
  • All other duties as necessary to the success of Corporation

QUALIFICATIONS:

  • Bachelor’s Degree in a science related field and 7 – 10 years of quality experience, including successful experience as a mid-level manage or equivalent level of experience
  • Proficiency in procedural and policy auditing, development, and implementation
  • Mastery of Root Cause, CAPA investigation, documentation and follow up to verify effectiveness
  • Experience with applicable 21 CFR regulations for Dietary Supplements, Infant Formula, Food, Feed preferred
  • Experience leading a Manufacturing Analytical Chemistry and Microbiology laboratory
  • Successful track record of effectively managing and developing staff within an entrepreneurial environment
  • Demonstrated management skills including delegation, time management, leadership, and mentoring
  • Proven ability to work collaboratively with operations team
  • Communicates clearly, written and orally, with all levels within an organization, both internally and externally
  • Demonstrated ability to work with and develop others in a team environment
  • Clear sense of urgency and ability to manage priorities to meet both immediate and long-term goals
  • Self-motivated with the ability to work independently
  • Advanced computer skills, specifically with Microsoft Office® products
  • Sensitive to other cultures/backgrounds, able to work in a multi-cultural workplace
  • Ability and willingness to learn, understand, and follow documented work procedures
  • Demonstrated ability to function in a fast-paced environment while moving multiple simultaneous projects forward

WORKING CONDITIONS:

  • While performing the functions of this job, the employee is regularly required to sit, stand, walk, talk, and hear