Quality Assurance Lead Specialist (4:00PM - 12:30AM)

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Job Summary:
The Quality Assurance Lead Specialist is a leadership level position that may have direct reports and is responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.


The What? · Execute and develop proficiency in all Level 1, Level 2 and Level 3 Quality Assurance tasks:
• Level 1:
o Manufacturing / Packaging Line Clearances
o Product Label Review and Approval
o Product Label Reconciliation
o EMS Data Review

o Logbook Review and reconciliation

• Level 2:
o Batch Record Issuance
o Batch Record Review and Approval
o Incoming Material Review and Approval
o Form and Logbook Issuance
o Review and Approval of Testing Data
o Review and Approval of Event Reports and Associated Corrective Actions


Level 3:
o Disposition and Release of Incoming Materials
o Disposition and Release of Finished Product
o Document Control Activities
o Review and Approval of Change Controls and controlled document changes
o Review and Approval of Moderate Risk Deviations

 May have up to three direct reports at the QA Generalist or Specialist levels.
 Completes administrative leadership tasks including, but not limited to task scheduling, KPI tracking, and individual performance monitoring.
 Demonstrated Subject Matter Expertise in all QA responsibilities relevant to assigned QA group. 3
 Takes on QA projects of low to moderate complexity as assigned.
 Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
 Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
 Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
 Assist with internal, corporate, 3rd party and federal/state inspections and audits.
 Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
 Ensure cGMP documentation associated with work activities meets ALCOA standards.  Maintain assigned training standard operating procedures.
 Perform other related duties as assigned. The How?
 Maintain the Fagron Family Values of Quality, Customer is #1, Transparency, Entrepreneurship, Creativity, and Speed of Execution while performing job responsibilities.
 Follow Fagron Family Rules  Contribute to QA Team success by participating in problem solving discussions and seeking to understand the “Why?”
 Strive for continual learning and improvement
 Develop Subject Matter Expertise (SME) in two or more QA functional areas (e.g., Doc Control, Release, QC Support, etc.)
 Lead by example for more junior QA staff.
 Actively develops and mentors junior staff and/or direct reports.
 Adheres to FSS policies and standards in managing any direct reports.

The How?
 Maintain the Fagron Family Values of Quality, Customer is #1, Transparency, Entrepreneurship, Creativity, and Speed of Execution while performing job responsibilities.
 Follow Fagron Family Rules
 Contribute to QA Team success by participating in problem solving discussions and seeking to understand the “Why?”
 Strive for continual learning and improvement