OVERVIEW

The Quality Assurance Lead reports directly to the Vice President of Operations and is responsible to oversee the internal quality and regulatory functions and work closely with various internal departments, Contract Manufacturer’s/Packers, and component suppliers on issues related to quality and regulatory.

DETAILED ROLES & RESPONSIBILITIES

QA/QC FUNCTIONS

• Regulatory and Customer inspections/audit support
• Finished product review, approval and release
• Coordination of RM, bulk and finished goods outside testing
• Finished good retain sample management

• Partners and communicates with sales and customer service departments and co-manufacturer on product complaint investigations and trends.
• Actively participate in department process improvement efforts.
• Perform root cause analysis, and CAPA as needed.
• Maintain Quality related metrics and scorecards.
• RM review, approval and release of customer owned material.
• Perform supplier qualification.

  
  

  RECORDS MANAGEMENT
  

• Product C of A review and approval
• Develop and maintain Finished Product Specifications (FPS)
• Manage stability program and develop reports as needed.
• Manage deviation log and change control.
• CAPA Management
• SOP Management (Systems, Review, Update, Training etc)

  COMPLAINTS & CUSTOMER RELATIONS

• Maintain complaint registry.
• Collaborate with co-manufacturer on complaint investigation.
• Immediately communicate to Sr. Management any critical and adverse related complaints received that need to be escalated.
• Review report from 3rd party adverse reaction partner and take appropriate action.

Qualifications and Experience

• Bachelor’s degree in science or related field and 5 years of experience in a GMP facility (food, dietary supplement, pharmaceutical) preferred
• Training in cGMP, FSMA and other related training
• Certification preferred such as ASQ, PCQI, etc
• Expertise in Microsoft Office
• Strong analytical abilities, extensive skills in spreadsheet analysis, and strong mathematical abilities.

  Required Attributes

• Ability to follow written and verbal policies and procedures.
• Excellent verbal and written communication skills including a high degree of professionalism when communicating to internal and external customers and partners.
• Strong interpersonal skills, excellent attention to detail and high organizational skills.
• Must be a self-starter, strong team player and able to work independently under limited supervision in a fast-paced, dynamic, team environment.
• Creative problem-solving skills