Quality Assurance Manager

Coordinates change control documentation and change control process. Disseminates change requirements to relevant departments. Provides regular feedback to Marketing and internally to the Product Group on customer requirements:

• Packaging and Labels – Design requests
• Maintains and Provides working files to the printers
• Processes “Check Before Print” requests for all packaging
• Ingredient Changes
• Web Labels

Creates and revises Standard Operating Procedures (SOPs) as part of quality documentation.

Works directly with the manufacturers on Product Complaints Resolution, Investigations, and CAPAs.

Performs external auditing of 3PLs to cGMP compliance.

Procures and manages information from CofAs of finished product (both domestic and foreign manufacturers) and produces quarterly reports or as needed.

Super User and member of Implementation team for Master Control, Quality Management System (QMS) software.

Arranges quarterly due diligence testing and special testing of products as needed.

Periodically review Stability Studies for shelf-life expansions or extensions.

Assists with requests from Epic Global/Amazon.

Serves on Packaging Waste Reductions team (PPWR)

• California AB 660 - Date Labeling Discussion
• Circular Action Alliance - US packaging
• New Master Pack Development

Actively participates in resolving quality issues. Works closely with other departments to achieve this goal. Makes suggestions for quality system improvements, recommends methods to increase the quality of products and/or services, and participates in the implementation of these improvements.

Actively serves on project teams and ensures timely completion of required tasks. This includes communicating directly with internal project teams and manufacturers.

May be asked to help with other departmental activities as required.

Qualifications & Experience

• Education: BS degree in a science-related field.
• Industry cGMP experience in a regulated dietary supplement, food, device or pharmaceutical environment.
• Audit experience desired but not required.
• Must be able to work independently, with minimal supervision.
• Effective interpersonal and team facilitation skills.
• Effective organizational skills and the ability to manage multiple projects effectively.
• Effective oral and written communication skills. Must be able to convey information to multiple levels of staff and management.
• Strong computer skills and knowledge of Microsoft Office programs (Word, Excel).

Training

Training will be required on SOPs and Good Manufacturing Practices at a minimum. Annual training outside of the company is desired.

Disclaimer

This job description is only a summary of the typical functions of the job, not a comprehensive list of all possible job responsibilities, tasks and duties.

Diversity, Equity & Inclusion are fundamental to our success. We are an Equal Opportunity Employer with people of different strengths, experience and background who are respected and celebrated for their race, color, national origin, gender, sexual orientation, age, religion, veteran status, disability, history of disability or perceived disability. We work in an environment where all our employees’ points of view are valued, and inclusion is everyone's responsibility.