The Lead Quality Assurance Specialist is responsible for establishing, deploying, and managing the Supplier Quality function. They oversee processes to ensure products and processes comply with internal and external regulations and quality standards. They work cross functionally with procurement, supply chain, QA, and scientific/production leads to identify, perform diligence on, and quality vendors. 

The Lead Quality Assurance Specialist works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.  The individual works on difficult assignments and understand the implications of the work, making recommendations for solutions. They determine methods and procedures on new assignments and completes tasks in resourceful and effective ways.  

1. Apply relevant quality standards and establish appropriate quality assurance processes to ensure compliance to those standards. Evaluate changes to industry standards and practices to improve the organization’s quality assurance systems. 
2. Develop processes for qualifying vendors to meet various quality standards ranging from research use to medical devices (13485) and cGMP applications. Develop and deploy vendor scoring processes and reporting systems.
3. Perform audits and evaluation of internal controls, suppliers, communications, risk management and maintenance of documentation, such as Standard Operating Procedures (SOPs), to assess compliance with internal and external safety, quality, and regulatory standards. Continuously evaluate the supplier corrective action (SCAR) process and manage corrective actions with the supplier based on incidents and trends.
4. Oversee the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents using industry standard document control, change control practices and information technology systems. Determine requirements for records retention, storage and disposal for business activities governed by the quality assurance systems. 
5. Lead collaboration of internal departments to identify nonconformities and support developing appropriate remedies and corrective actions. Identify risks and ensure departments develop preventative actions.
6. Develop and deliver internal training on quality assurance requirements, processes, and procedures. Mentor and train quality assurance staff to perform quality assurance activities in accordance with the established quality assurance systems. 
7. Schedule, plan, and lead internal and vendor audits and risk assessments to ensure compliance with documented procedures. Prepare and present audit reports. Support departments with resolution and monitoring of any identified action items. 
8. Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review. Support management in evaluating organizational performance against quality goals and assist in developing performance improvement plans. Assist with the implementation of any resultant action items. 
9. Advise internal customers to support achieving organizational quality goals and objectives while ensuring compliance to organizational SOPs. 
10. Perform duties on behalf of the Manager, Quality Assurance, as delegated.

Education and Experience:

• Bachelor's degree and 8 or more years' experience, including 0-2 years' supervisory experience or equivalent experience.

Knowledge, Skills and Abilities:

Travel Requirements:

• Travel is required (estimated 10%)

 Other Duties:

• Perform other duties as assigned.

Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.