QUALITY ASSURANCE MANAGER jobs in Utah

The Quality Manager will Direct, Analyze, Implement, and Manage Quality Policies, Procedures, and Performance related to FDA 21 CFR Part 111 current Good Manufacturing Practices (cGMP), DSHEA, and other applicable regulations. This is not a remote position and will require the employee to be on location

Position Reports to General Manager

Duties and Responsibilities

· Assure GMP Compliance with FDA CFR 21 Part 111, DSHEA, and other regulatory and third-party certification guidelines is maintained throughout the company.

· Create, implement, and evaluate the effectiveness of written QA/QC Standard Operating Procedures (SOPs) and related forms and documents.

· Assure that all QA/QC documentation is maintained, updated, reviewed, and approved to reflect current processes.

· Training of all personnel in cGMPs and QA/QC procedures related to their specific job function.

· Manage qualification and oversight of contract vendors used for manufacturing, packaging, labeling, warehousing, distribution, or laboratory services.

· Develop and oversee testing programs for all finished products.

· Determine the disposition of the finished product after reviewing batch records, lab test results, product samples, and internal tests.

· Assure that all complaints and adverse events are recorded and investigated as necessary, and are closed out upon resolution.

· Serve as facility escort and coordinator of all audits related to GMPs, QA/QC.

· Report to the President any quality or regulatory issues that need to be addressed, and communicate with Regulatory Agencies as required.

· Manage content for cartons and foils for LivOn products. Manage content updates with designers, as needed/required.

Qualifications and Requirements

· A bachelor’s degree or equivalent in Chemistry, Biology, Nutrition Sciences or other related field

· 3 years of experience in QA/QC management

• 3 years of experience in Dietary Supplements preferred

· Working knowledge of current Good Manufacturing Practices (cGMP) for Dietary Supplements

· Strong attention to detail and good organizational skills

• · Strong written and verbal communication skills