Manager Thermal Processing and Regulatory Compliance Program

About Amys

At Amys Kitchen were more than just a food companywere a familyowned proudly independent organic and vegetarian food company on a mission. As a Certified B Corporation our purpose is clear: to make it simple and enjoyable for everyone to eat well.

Were committed to crafting authentic mouthwatering dishes using only the finest organic ingredients sourced with care. From farm to table we ensure topnotch quality in every bite making healthy eating accessible and convenient for all. At Amys were not just serving meals; were serving up a taste of goodness one delicious dish at a time.

Perks are as delicious as our meals!

Comprehensive health plans with Medical Dental and Vision coverage plus Flexible Spending Accounts. Mental health support with Modern Health to nourish your and your familys mental wellbeing. 401(k) Retirement Plan with employer match and Financial Wellness support at no cost to plan for the future. Referral Rewards and Scholarship Program to celebrate and invest in our teams. Tuition Reimbursement Program to fuel your educational pursuits. Paid parental leave for new parents. Paid Time Off for vacations and sick days with 9 paid US Holidays annually to savor those special moments. Amys product discount reimbursement to keep your pantry stocked plus remote gym discounts to keep you moving and grooving! Join us and indulge in a career where the benefits are as fulfilling as our food!

The incumbent will manage compliance activities relating to regulatory affairs at Amys Kitchen on an enterprise level with facilities located in Santa Rosa CA Medford OR and Pocatello ID. They will work closely with key stakeholders across the business including Food Safety and Sensory Manufacturing Sourcing Information Technology and other impacted departments. This role will ensure compliance with regulatory requirements both domestic and international thirdparty audit requirements and customer requirements. This position will also manage and oversee the Thermal Process compliance program to ensure compliance with all applicable regulations for low acid acidified and acid foods. This role serves as technical support for thermal processes across all facilities. Oversight of this program includes development and support of the file review process technical support on hold disposition and process deviation leading new equipment approvals ownership of the relationship with Thermal Process consultants training to applicable team members in Food Safety and Sensory and Manufacturing and collaboration with the R&D for the commercialization process for thermally processed shelf stable products.

• Work closely with management team to ensure compliance with international (EFSA CFIA etc. Federal (FDA USDA) State and local regulatory requirements throughout the supply chain including sourcing of raw materials commercialization production and distribution.
• Support holds disposition process for shelf stable thermally processed products working with both internal and external entities
• Act as companywide subject matter expert on shelf stable thermal processing technologies focusing primarily on Low Acid Canned Foods (LACF) and Acidified Foods
• Provide technical input and work with process authority as needed for dispositioning deviated products against schedule processes.
• Support companywide initiatives to continually improve processes relating to production food safety and sensory and compliance working with various stakeholder departments within the company
• Act as technical expert in assessment of raw material issues relating to thermal processing for both safety and quality
• Ensure that Amys Canning procedures and programs are consistent with 21CFR Part 113 and Part 114 (acidified foods) as well as Canadian and international low acid canned food and acidified foods requirements where applicable.
• File Process Letters with the FDA (LACF and Acidified) and maintain current copies of Scheduled and Operating processes at all Amys facilities.
• Coordinate and maintain training records and certification for Better Process Control School and related training activities at all Amys facilities.
• Support and conduct thermal/acidification process audits provide recommendations to close gaps and support operations to close gaps.
• Where applicable manage validation activities related to CFR Part 11 Electronic Records
• Verify maintenance of Deviation Log for FDA review.
• Forward deviations to Process Authority (when necessary)
• Partner with Culinary (R&D) as well as Food Safety and Sensory to oversee conduction HP trials and process validation work for new products and reformulations
• Work with Engineering as a subject matter expect regarding equipment related to thermal processing line; including but not limited to line design selection of equipment participation in Factory Acceptance Testing and validation of new or existing equipment.
• Remain current on new technologies and industry best practices and changes in regulatory requirements relating to thermal processing. Communicate this information to the management team as appropriate.
• Research new and existing regulatory information related to processing raw materials recipes finished goods and make recommendations regarding compliance requirements and strategies for domestic and international
• Interpret and apply regulatory rules rule changes and customer requirements to determine impact on the company and appropriate Report findings to the leadership group as necessary and ensure requirements are appropriately communicated through corporate policies.
• Provide input and training from a regulatory standpoint to ensure Amys procedures policies and document control systems are compliant and up to date
• Assist in ensuring timely turnaround and accurate responses to all governmental agencies and customer inquiries regarding regulatory food safety and quality
• Actively maintain current knowledge of existing and emerging regulations guidance documents hotbutton issues industry standards regulatory warning letters and customer requirements. Recommend and provide guidance on company procedures and policies based on this knowledge.
• Regularly review FDA recalls FDA warning letters Import Alerts and CFSAN Adverse Event Letters. As appropriate report findings to management or the Regulatory Bulletin email group and implement corrective measures or process improvement as needed.
• Conduct regular regulatory update meetings with staff at each production location
• Perform regulatory reviews such as the Food Fraud Vulnerability Assessment Annual Pesticide Testing Assessment and Corporate Mock Recall.
• Plan and manage activities or projects in response to emerging issues to mitigate and manage risk to the
• Provide regular updates covering recent and relevant regulatory topics and/or emerging issues of significance to Amys to the Senior Management
• Serve as a company representative and/or technical liaison with the Amys Legal Team regulatory and professional organizations and appropriate departments within the
• Develop and maintain both formal and informal relationships (networking) with regulatory agencies consultants legal entities and customers both domestically and internationally as needed.
• Represent regulatory perspectives within key business functions including but not limited to commercialization international sales consumer and customer inquiries manufacturing import and export) Sensory Supplier
• Participate in and provide input to sanitary design process for new equipment production lines processing areas and facilities. Attend meetings as
• Assist in developing and managing the budget allocating resources and planning activities for the Regulatory
• Oversee certifications function (Kosher Vegan NonGMO Coeliac etc. to ensure we are in compliance with all product
• Support regulatory aspects and customer requirements relating to Sustainability and Social Responsibility as
• Advise and provide guidance and support relating to regulatory third party customer and certification audits
• Provide support for training needs relating to regulatory compliance on topics such as FSMA organic certification audits product weight and coding requirements
• Work to ensure that regulatory compliance becomes part of our continuous improvement effort.
• Lead on or support initiatives called out in in our Objectives Goals Strategies and Measures (OGSM) within the Food Safety and Sensory
• Other projects and duties will be assigned as necessary to support our regulatory compliance effort

It is the responsibility of all employees to uphold the mission of the Amys Food Safety and Quality Policy. This includes following all Food Safety and Sustainability programs and participating in all required.

Supervisory Responsibilities
This position supervises one Food Technologist.

Key Food Safety Personnel

• This position is identified as a key food safety role with the authority to initiate actions related to food safety and report food safety problems. In their absence the Senior Food Safety and Sensory will provide coverage on all shifts.
  

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

• Minimum BA/BS degree in Food Science and Technology with a concentration in QA/QC and regulatory compliance; or a degree in a related Life Science from a four year college or university.

Experience

• Minimum of 5 years of food safety and technical experience with food and food related products (including food laws and regulations) within a QA/QC
• Minimum of 3 years management experience.
• Completion of Better Process Control School
• Knowledge of and training in process development process deviations and acidified foods
• Knowledge experience and proficiency with thermal processing programs; including CalSoft NumeriCAL ValSuite and related programs.
• Valid Drivers License

Preferred:

• Project Management experience.
• Knowledge of GFSI (SQF) CI and RCA methods
• SQF Practitioner
• PCQI (Preventive Controls Qualified Individual Human Foods) Certification
• PCQI Lead Instructor (LI)
• Recommended Member of Institute for Thermal Processing Specialists (IFTPS).

Skills

• Excellent communication skills; ability to relate to all internal levels as well as interface with suppliers and government on a technical
• Exceptional interpersonal and assertive skills necessary to maintain effective and cordial working relationships while being the person whose foremost responsibility is regulatory
• Team player. Works well with food safety staff local plant management and corporate
• Ability to assess risk and make decisions both collaboratively and independently based on multiple
• Ability to review assess distill complex regulatory documents and present with recommendations for decision
• Detail oriented.
• Reliable/Dependable.
• Preferred:
• Knowledge of food product
• Membership in IFT ASQ

Language Skills

• Ability to read analyze and interpret common scientific and technical journals financial reports regulatory customer and legal
• Ability to respond to common inquiries from regulatory agencies customers or members of the business
• Ability to effectively present information to top management public groups and/or boards of

Mathematical Skills

• Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and
• Ability to apply concepts such as fractions percentages ratios and proportions to practical

Reasoning Ability

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

Certificates Licenses Registrations

• None required.
• SQF Practitioner and HARPC Qualified Individual preferred.

Travel

Estimated travel requirements are approximately 20.

Physical Demands

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

While performing the duties of this job the employee is frequently required to sit stay in a stationary position stand; use hands to finger handle or feel talk or hear. The employee is sometimes required to walk move around an office or plant location reach with hands and arms and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision color vision depth perception and the 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.

This position is exposed to a work environment where the noise level is moderate i.e. business office with computers and printers light traffic and office conversation.