Job Description

Company Profile

"Enhancing the Lives of Those We Touch by Helping People Reach Their Goals”

At Melaleuca, our focus is on wellness and everything we accomplish is done with an eye toward promoting the physical, environmental, financial, and personal wellness of those around us. We have provided a stable work environment for our team members while achieving consistent and profitable growth with our annual revenues consistently exceeding $2 billion dollars. We have over 5,000 employees and operate in 21 countries around the world. Melaleuca is positioned to grow even more rapidly in upcoming years.

The QA Auditor will direct and conduct all quality audit activities. As such, outlines, originates, and performs audits both internally, and with vendors to ensure compliance to company and regulatory guidelines.  Leads efforts in process improvements related to audit findings.

Responsibilities

• Coordinates internal audits of plant(s) for compliance to Federal Food, Drug, and Dietary Supplement GMP laws and internal procedures.
• Coordinates vendor audits to assess their ability to comply with company specifications and meet GMP requirements.
• Assists QA manager/director during FDA and other regulatory agency inspections.
• Coordinates the audit of documentation and recommends document changes for the plant.
• Researches possible causes and provides feedback regarding product quality issues raised by audits.
• Keeps current on regulatory actions in the Food, Drug, and Dietary Supplement industry.
• Writes internal and vendor audit reports.
• Works with vendors and purchasing to assure continuing conformance to specifications of incoming labels, components, ingredients, and outside-manufactured products.
• Keeps current on QA inspection results and procedures.
• Performs routine audits on historical batch records and other past OTC and DS documentation.
• Coordinates the yearly GMP awareness and compliance training.

Qualifications

• Bachelor’s degree with 8 years manufacturing industry experience with at least 4 years experience with Quality Audits or working with vendors.
• A working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products, Dietary Supplements and Foods
• Experience with FDA audits helpful.
• Self starter.
• Excellent verbal and presentation skills.
• Ability to organize and coordinate projects.
• Ability to travel (maximum 15% of the time).
• Ability to write meaningful, accurate, and concise reports.
• Ability to perform multiple tasks in a fast paced setting.

Just as important as your experience and skills will be the following characteristics and competencies:

• A natural orientation for continuous improvement and problem solving.
• A collaborative approach and willingness to engage in an environment of active idea sharing. 
• Strong ability to multi-task in a fast-paced environment.
• The ability to produce consistent quality under deadline pressure while paying careful attention to detail.
• Performs other duties as assigned or needed.
• Provide supervision to QA associates as required by the position.
• Act as plant customer service liaison.
• Destruction or storage of outdated documents according to guidelines.