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Regulatory Affairs Specialist II
Arizona Nutritional Supplements     Chandler, AZ 85226
 Posted 1 day    

About the Company:

ANS provides industry-leading nutritional solutions to promote health and wellbeing, enabled by a world class team dedicated to service, excellence, quality, and innovation.

As an organization we take pride in achieving our objective of “More than Supplements... Solutions”... Safety. We want to be a “solution” through an engaged, accountable, and CARING culture.

If you are looking for an exciting career opportunity with a company that offers exceptional benefits packages, then you have come to the right place!

Most Competitive Pay in the Industry
401K Program
Paid holidays
Paid Time Off
Medical/Dental benefits
Employee and Family Events
Annual Awards Program
Best Employee Referral Program

The Opportunity…

Strong track record of internal promotions

Comprehensive Training program to encourage promotions

Detailed Progression model to outline promotional opportunities

Cross-functional opportunities to multiple different areas in the company

Requirements

Follow all company policies and procedures.

Follow and ensure compliance to quality system, Current Good
Manufacturing Practice, Food Safety Modernization Act, and all regulatory and company food and dietary supplement programs.

Track and report on regulatory changes.

Assist in audit preparation and closure of corrective actions.

Assist Sales and Customers with technical document requests.

Primary reviewer of Raw Material Specification Change Orders.

Communicate complex information and instructions plainly in technical writing and graphic communications, including standard operating procedures, manufacturing flow maps for export and

Preventive Control hazard risk analysis, spreadsheets, charts, graphs, reports, and presentations.

Coordinate with suppliers and customers as needed.

Ensure that programs and plans comply with regulatory requirements.

Responsible for vendor requalification and service provider qualification program.

Submit products for certification and provide lead support for certification programs such as

Non-GMO Project, Organic, Kosher, Halal, MSC, NSF, etc.

Lead support for resolving receiving holds.

Assist with maintenance of Internal Audit Program.

Collaborate inter-departmentally and externally with certification agencies to resolve Quality, Regulatory, and Certification Compliance issues expeditiously.

Qualifications

Must have a high school diploma or equivalent.
Two years of experience in an FDA-regulated industry preferred.
Must obtain PCQI and FSVP Certification within 1 year of hire.
Must have moderate math skills and data analysis skills.
Complex reading skills required, including relevant regulations.
Complex computer skills required. Proficiency in Microsoft Excel, Word, Visio, and Adobe Acrobat Pro.
Must have complex language skills, including technical writing and instructional design skills.
Must be willing to learn new tasks and procedures and be able to train others.
Must be able to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to self or others.
Maintain a regular and dependable work attendance record with few instances of unplanned and/or unexpected absence.
Must have experience with managing and building workflows in document management systems.

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Job Details


Seniority Level

Some work experience (up to 5 years, non-manager)

Industry

Manufacturing

Employment Type

Full Time

Number of openings

N/A


Related Skills:


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