The Associate Quality Assurance Specialist is responsible for supporting the maintenance, adherence to, and improvement of processes that promote consistency, identification of deviations, prevention of defects, and elimination of problems before they occur. They ensure products and processes comply with internal and external regulations and quality standards. They assist in the development, implementation, and administration of the Quality Assurance Program.

This is an entry level role with varied duties to assist in the repository with line clearance in the lab, verifying production orders and assisting with inspections.  Must be able to be successful in fast paced environment with multiple priorities.  Great learning opportunity for someone looking to advance in QA.  

The Associate Quality Assurance Specialist works on problems of limited scope. They perform routine work assignments with direct oversight. They are trained by and work under direct guidance or supervision of senior staff to execute new projects or assignments. They follow standard practices and procedures in analyzing situations or data from which answers can be readily obtained. 

The Associate Quality Assurance Specialist supports cGMP operational activities of receipt and inspection of incoming materials, label and line clearance activities, audit trail data review and environmental monitoring data review.

1. Assist and support the organization with initial compliance and ongoing monitoring of conformance to established quality assurance processes and standards in performing work governed by the quality assurance systems, to include manufacturing and production as well as customer service. 
2. Support the evaluation of internal controls, 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.
3. Work with internal departments/business units to identify nonconformities and assist in developing appropriate remedies and corrective actions. Identify risks and support departments in developing preventive actions as directed.
4. Assist with the facilitation of internal training on quality assurance requirements, processes, and procedures.
5. Support 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.
6. Assist with development and implementation of SOPs and follow requirements for records retention, storage, and disposal for business activities by the quality assurance systems.
7. Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents.
8. Prepare, maintain, analyze, and present metrics related to quality assurance activities for monthly reports and management review.
9. Assist with issuance, control, and maintenance of documentation according to established quality assurance systems, using industry standard document control and change control practices and information technology systems.

Education and Experience:

Knowledge, Skills and Abilities:

• Excellent interpersonal and communications skills.
• Excellent organization and analytical skills.
• Ability to work alone or within a team environment.
• Ability to foster high degree of customer satisfaction.

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.