Quality Systems and Regulatory Specialist

SUMMARY

The Quality Systems and Regulatory Specialist is responsible for the harmonization and utilization of quality data to support effective decision making related to the manufacture of safe, legal, and authentic products that deliver on the requirements of our customers and Company. In addition, this individual will respond to internal and external customer requests for quality and technical information and documentation with regards to Bay State Milling Company (BSMC) business, products, and manufacturing facilities. The Quality Systems and Regulatory Specialist is a member of Corporate Quality Assurance (CQA) and will work closely with other departments and functions as needed.  This role will support the drive for business results by executing tasks in key focus areas identified by QA and BU leadership utilizing data to execute opportunities such as: standardize product offerings, improve product quality, or reduce costs while maintaining compliance to standards. This position will provide opportunities to actively participate in and support Continuous Improvement (CE) projects, contributing to the implementation of identified changes and driving desired outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES include, but is not limited to the following: 

Other duties may be assigned.

• Manage and maintain up to date documents and information per customer requirements on all applicable 3rd party portals, websites, internal BSMC shared areas, including BSMC Customer Portal.
• Provide recommendations of updates to the BSMC Customer Portal based on the company and customer’s evolving needs and requirements.
• Maintain technical bulletins and other technical documents by conducting periodic reviews with the CQA Regulatory Leadership team.
• Onboard new Vendors and Raw Materials through the approval process
• Assemble and facilitate team meetings to conduct reviews and approval of customer specifications and Supplier Expectation Manuals in a timely manner.
• Support local QA teams with annual renewals of certifications (organic, kosher, non-GMO, etc).
• Work alongside CQA Regulatory Leadership and other management in managing FDA holds by requesting lab quotes, managing FDA notifications, communicating with FDA Compliance Officers and inspectors, and providing guidance on releases or refusals to local teams.
• Serve as a secondary admin to Alchemy training software for Bay State Milling
• Serve as a Quality AX SME and be a resource for building reports.
• Lead the CQA portion of AX item creation or updates to support business units including formula building, assigning quality attribute groups, assigning base ingredients and allergens, and generating product labels
• Serve as Tier 1 site support for Quality related AX issues while also acting as quality liaison for AX development team.
• Conduct internal quality audits to support compliance with applicable regulations, Company policies and procedures, as well as customer requirements
• Function as the Systems Subject Matter Expert providing support and knowledge of Quality systems for assistance to other BSM Employees for ERP design and implementation.

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Education and/or Experience:

• Bachelor’s degree (B.S.) in a related field such as accounting, food science or similar applicable field.
• Minimum of 2 years with the company or previous experience in the industry.
• Attention to detail and strong organizational skills required.
• Must be able to demonstrate excellent communication, relationship building, and collaboration skills.

Language Skills:

Capable of following and communicating written and verbal instructions in English.  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write in English and complete reports, business correspondence, and procedure manuals.  Ability to effectively present or sensitively respond to questions from groups of managers, customers, top management, public groups, and/or Boards of Directors by providing applicable information.

Mathematical /Computer Skills:

Demonstrated aptitude and practical experience in the use of computer programs such as spreadsheets, presentation formats, word processing, statistical programs, and web-based applications. 

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables at any given time.

OTHER SKILLS & ABILITIES

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee successfully performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit or stand. The Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is generally exposed to a non- manufacturing, office type environment and not subject to noise, dust, industrial type machinery.

FOOD SAFETY/SECURITY AND QUALITY REQUIREMENTS:

The Company is committed to producing and delivering defect-free products. To ensure this, all employees are required to be trained in and adhere to the Good Manufacturing Policies set forth by the Company as they pertain to personnel practices, equipment, and facilities.  It is also vital that all employees be aware of the work environment and when possible, prevent accidental or intentional adulteration of products produced at this facility.  As a result, any employee has a right to put product on hold if they have a concern.  At the plant level, only the Quality Assurance Manager or designee have the authority to release products on hold.

SAFETY

While performing the essential job functions, the employee is expected to work in a safe manner and follow company policies regarding safety.  It is the expectation and responsibility of the employee to report any and all injuries immediately to the supervisor, and to report to supervision any safety situation that the employee feels is substandard and poses a risk for employee injury, property damage, or loss.