Quality Systems Lead

About the Role:

The Quality Systems Lead is responsible for supporting Quality Assurance functions, primarily focused on establishing and maintaining processes to ensure compliance with internal and external requirements and regulations. This is an onsite position at our laboratory location in Longmont, CO. 

Core Expectations:

• Manages and designs forms, workflows, applications, and analytic dashboards in the Quality Management System (QMS) Cloudtheapp.
• Assists in QA management of employee accounts in the QMS
• Leads routine meetings with the QMS developer to discuss system modifications, upgrades, and issues. 
• Trains employees on how to use the QMS while monitoring training completions
• Conducts annual GMP training
• Manages and monitors document control including new creation, reviews, and updates of SOPs.
• Leads weekly Change Management meeting; initiating, documenting, and completing changes in the QMS
• Creates new and revised master specification, label, and similar records
• Leads Internal Audit program
• In combination with other QA personnel:
  • Supports biannual Management Review for a quality assessment of the company
  • Reviews and approves Certificates of Analyses (CofAs) and other internal analytical testing reports
  • Reviews batch records received from the contract manufacturers for accuracy and completeness
  • Assists with customer feedback investigations, compiling information from relevant departments to solve issues.
  • Writes and/or reviews deviations, CAPAs, and other quality records

Qualifications and Success Factors:

• Bachelor’s degree in a scientific discipline or engineering in a dietary supplement, food manufacturing, or pharmaceutical industry preferred.
• 2 or more years of relevant QA experience.
• Experience with electronic Quality Management Systems and the change control process.
• Internal Audit training strongly preferred
• Six Sigma training is a plus

Competencies & Skills:

• Strong software skills, including Microsoft Word and web based quality management systems
• Strong communication skills in-person and through messaging and video calls
• Leadership courage with the ability to speak strongly in group settings
• Action oriented to drive completion of quality related tasks and records
• Strong attention to detail, particularly in quality documentation
• Flexibility for changing priorities and the eagerness to take on varied responsibilities