Primary Function:

Responsible for the oversight of all Quality Operations in the Vetio Animal Health food facility in Jupiter, FL, including those related to Quality Assurance and Food Safety Programs as well as the quality of all products produced. The Quality Assurance Manager will ensure compliance with all local, state, federal, company, and customer requirements and maintain current regulatory registrations, permits, and cGMP regulations related to CFR 507.

Key Responsibilities:

· Oversee and ensure compliance with all local, state, and federal regulatory requirements

· Oversee and ensure compliance with all company and applicable customer programs and requirements designed for production safe, quality products

· Develop, revise, and implement all Quality Systems related to animal food safety

· Ensure that all established Quality Systems will yield finished products that meet all purity, quality, and composition standards

· Maintain the final authority to approve or reject all procedures, specifications, controls, test methods, and results that impact the purity, quality, and composition of ingredients or products

· Supervise and designate quality employee review and approval of all master manufacturing records, and all modifications to the master manufacturing records

· Ensure the following Quality Programs are maintained according to cGMP standards:

o Food Safety

o Corrective Action Preventative Action (CAPA)

o Deviation

o Quality Incident Reporting

o Complaint Handling

o Change Control

o Training

o Internal Auditing

o Quarantine/On Hold

o Supplier Qualification and Foreign Supplier Verification

· Review and approve equipment, process, and cleaning validations

· Review and approve laboratory control processes and testing results, as needed

· Review and approve the documentation for qualification of suppliers, both foreign and domestic

· Develop, approve, and maintain customer quality agreements

· Maintain authority for disposition of ingredients, in-process materials, finished products, and packaging materials

· Have the authority to control and release withheld and retained product

· Responsible for hosting customer and regulatory auditors

· Responsible for responding to customer and regulatory audit observations

Skills & Knowledge Required:

· B.S or higher required

· Extensive Knowledge FDA CFR 507 requirements

· At least 10 years’ experience managing a Quality Assurance group

· At least 10 years’ experience in FDA/GMP environment with at least 5 years in a food manufacturing environment

· PCQI certified, animal food preferred

· HACCP certified

· GMP Professions certification preferred

• SAP Experience a Plus

· Experience communicating with customers

· Experience hosting and/or participating in regulatory audits

· Ability to manage multiple projects and prioritize demands

· Strong organizational skills

· Strong analytical skills with attention to detail

· Self-starter/motivated

Physical Requirements/Work Environment:

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Frequently required to stand; walk; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear

· Frequently required to sit

· Occasionally lift and/or move up to 25 pounds

Note: This job description is not intended to be all-inclusive. The employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• FDA CFR 507 requirements: 3 years (Required)
• PCQI Certified in Animal Food: 1 year (Required)
• HACCP: 1 year (Required)
• Quality management: 10 years (Required)
• FDA/GMP: 10 years (Required)

Work Location: In person