Director of Quality and Regulatory Affairs

LaCore Nutraceuticals • Full-time • Van Alstyne, Texas, United States • $67.78k - $108.26k / year • 4w ago

SUMMARY:

The Director of Quality and Regulatory will oversee the Food Safety, Quality Plans, and Regulatory projects for LaCore Nutraceuticals products, line extensions, quality improvements and productivity initiatives. The Director of Quality and Regulatory will provide leadership and direction to a team of technically skilled direct reports and the position will serve as the point of contact and subject matter expert on all food safety, quality, and regulatory topics assigned. As needed, the Director of Quality and Regulatory will engage in activities with equipment manufacturers, industry colleagues, and regulatory agencies.

RESPONSIBILITIES:

· Responsible for maintaining food safety, quality standards, and customer specifications.

· Ensures product safety, regulatory compliance, and compliance with company policies and directives.

· Engages in the typical responsibilities of a Director requiring planning, evaluating, organizing, integrating, and delegating.

· Provide Quality and Food Safety expertise/direction/support to the organization as it relates to manufacturing of new or existing products and package design.

· Develop, implement, and monitor company policies and procedures related to food safety and quality control.

· Responsible for cGMP, HACCP, SOP and SSOP program documentation.

· Leads by example this includes following Company policies, standards and specifications.

· Continually examine and review plant processes to identify and remove potential areas of concern. Emphasis on continuous improvement.

· Conduct internal audits ensuring the current processes/procedures, specifications, and documentation is being used.

· Develop and maintain documentation of all required quality tests and activities. Prepare and create reports.

· Manage, train, schedule, and direct Quality Assurance and Quality Control Managers and Team Leads.

· Ensure all samples for chemical and microbiological testing are correctly sampled and analyzed.

· Coordinate and in some cases perform the technical qualification of potential new co-manufacturing facilities and/or new equipment installations to ensure quality and food safety expectations are met.

· Ensure risk assessments are conducted on all projects including robust mitigation (preventative controls) and contingency plans.

· Administer technical guidance on projects to ensure processes and equipment are capable of meeting company standards for quality and food safety.

· Stay current with all key regulatory and certifying agency requirements.

· Investigate customer complaints and/or events, determine root cause, and implement necessary corrective action and preventative controls.

· Serve as the subject matter expert and point of contact for all regulatory and cGMP compliance audits.

· Provide project and team status updates regularly to Senior Leadership team.

· Partnering with senior leadership to identify, analyze, and accelerate strategies for growth and continuous improvement.

· Performs other duties as assigned.

SUPERVISOR RESPONSIBILITIES:

· Supervise, develop, provide feedback, and coach employees.

· Responsible for employee selection, retention, disciplinary action, and performance management.

· Held accountable for food safety and quality of LACORE Nutraceuticals products.

· Adhere to and enforce all required work safe practices.

SKILLS AND ABILITIES:

· Possess expert knowledge of quality topics; Food products, Dietary Supplements, Microbiological testing, Regulatory guidelines, 21 CFR guidelines, HACCP, HARPC, Food safety and defense, cGMP, Pest management, Allergen control and sanitation practices.

· Have a working knowledge of all procedures and processes within the manufacturing environment.

· Demonstrate professional leadership while being a team player working across multiple functions and disciplines.

· Proficient in Microsoft Office Suite (Excel, Word, Outlook, etc..) and computer-based applications.

· Excellent verbal and written communication skills.

· Skilled in organization and prioritization, and attention to detail.

· Must be able to work in an environment where you are exposed to sensitive food ingredients and allergens.

· Willing to work flexible hours including overtime, weekends, and holidays.

· Work well in a fast-paced and always changing manufacturing environment.

· Required to pass all pre-employment screens (including drug, background, and criminal checks).

EDUCATION AND EXPERIENCE:

· College Degree or equivalent required.

· Associates or Bachelor’s degree in Food Science or science-related degree required.

· HACCP and SQF Practitioner certification required.

· 10 years’ experience in Quality Assurance/Quality Control in the food Industry.

· 5 years’ experience in a managerial capacity.

PHYSICAL DEMANDS:

· Occasionally (up to 3 hrs.) walk or stand, reach below shoulder level, stoop/kneel/crouch throughout the shift.

· Frequently (up to 6 hrs.) lift or carry up to 25 pounds.

· Occasionally (up to 3 hrs.) push/pull up to 25 pounds.

· Frequently (up to 6 hrs.) sit, use hands/fingers, and view computer screen.

Job Type: Full-time

Benefits:

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

Schedule:

8 hour shift
Monday to Friday
Weekends as needed

People with a criminal record are encouraged to apply

Education:

Bachelor's (Preferred)

Experience:

Managerial: 5 years (Required)
QA/QC in the food industry: 10 years (Required)

Ability to Commute:

Van Alstyne, TX 75495 (Required)

Ability to Relocate:

Van Alstyne, TX 75495: Relocate before starting work (Required)

Work Location: In person

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