Quality Assurance Specialist

Ready to shape the future of science and global health? ATCC, a leading nonprofit biological resources and standards organization, is seeking a Quality Assurance Specialist. This role is responsible for maintaining, ensuring adherence, and improving upon processes that promote consistency, identifying deviations, preventing defects, and eliminating problems before they occur. They ensure products and processes comply with internal and external regulations and quality standards. They support the development, implementation, and administration of the Quality Assurance Program.

The Quality Assurance Specialist works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. They perform routine work assignments with minimal oversight. They are trained by and work under direct guidance or supervision of senior staff to execute new projects or assignments. They perform within defined procedures and practices and work with senior staff where judgment is required to determine appropriate action.

Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

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.
1. Evaluate 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.
2. Work with internal departments/business units to identify nonconformities and support developing appropriate remedies and corrective actions. Identify risks and support departments in developing preventive actions.
3. Facilitate internal training on quality assurance requirements, processes, and procedures.
4. Support or conduct 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.
5. Assist with development and implementation of SOPs and determining requirements for records retention, storage and disposal for business activities by the quality assurance systems.
6. Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and changes of documents, while also maintaining physical and archived documents.
7. Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review.
8. Advise internal customers to support achieving organizational quality goals and objectives while ensuring compliances to organizational SOPs.
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:

• Bachelor's degree and 2-5 years' experience or equivalent 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.

We Invest in You

• Health & Wellness:
  • Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D
  • Work life balance with Paid Holidays and PTO
  • Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance
  • Employee Assistance Program offering around-the-clock counseling
• Financial security:
  • 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  • Exceptional career advancement opportunities, recognition, and rewards
  • Corporate bonus program
• Mission Focused:
  • Non-profit organization supporting critical life science research
  • We give scientists the tools they need to make discoveries that improve and save lives
  • Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.