FDA Compliance Specialist

Balance of Nature - Saint George, UT (9 months ago)

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Balance of Nature is looking for an FDA Compliance Specialist. This role requires a firm understanding and working knowledge of current FDA GMP requirements. This person should have the ability to apply this knowledge to Balance of Nature’s current SOP’s.

ESSENTIAL DUTIES AND ACCOUNTABILITIES:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Initially, this person will be establishing and writing SOP’s. They will also be participating in training management and employees on the procedures that are implemented.

The requirements listed below are representative of the knowledge, skill, and/or ability required as the position develops and grows! This is an amazing opportunity to step into a position with such growth potential. Balance of Nature has been around for over 20 years and doesn’t stop growing!

Champion and manage the Quality Control Division of our manufacturing facilities.
Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.
Drafts corrective action responses associated with state, federal and customer audits observations, and reviews these with FDA Divisional Director before release.
Creates deviation requests and submits these to Division Director of FDA Compliance for review.
Oversees the investigation of serious complaints.
Ensures that any procedural revisions are communicated to the manufacturing facilities and training is conducted.
Assist in providing compliance audit and Annual Product Review feedback to business entity leadership.
Monitor performance against Quality standards and champion suggestions for continuous improvement.
Work in partnership with all operating companies and service-related departments to develop, champion, implement and sustain Quality and FDA Compliance strategies, policies, standards, guidelines, processes and best practices. Work with peers to develop best practices.
Champion teams of experts in the Quality and FDA Compliance Department to develop, implement, and sustain integrated best practices, processes and tools.
Qualifications

EDUCATION and/or EXPERIENCE:
5+ years of experience in the administration of compliance with FDA. College degree a plus.
Demonstrated success in management of significant projects in diverse organizations.
Knowledge of local, state and federal laws pertaining to production of supplements.
Must be able to discern and explain government (cGMP and FDA) regulations.
Prior experience working with FDA compliance rules and regulations preferred.
Experience resolving compliance and regulatory issues in collaboration with company owners and founders.
Ability to maintain confidentiality of records.
Must have excellent verbal and written communication skills and excellent organizational and time management skills.
Ability to deal with all levels of associates within the organization.
Must like to do a wide variety of tasks and have the ability to be multi-tasked.
Must be proficient in Work, Excel, PowerPoint and Outlook.
Ability to work independently and under pressure to meet deadlines.
About Balance of Nature & Premier Health

At Premier Health we provide Balance of Nature’s whole food supplements and coach our clients to implement lifestyle changes to improve their health. We serve thousands of people helping them become active, healthy, and happy. We work hard and have fun doing it! We are looking for like-minded people to join our team.