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Senior Quality Assurance Engineer

Gaithersburg, MD
Start date
Nov 20, 2023

View more

Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
BioCapital, Best Places to Work

Job Details

Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking a Senior Quality Assurance Engineer for an onsite role based in Gaithersburg, MD.   


The Senior Quality Assurance Engineer oversees planning, implementation, and compliance of manufacturing processes, ensuring adherence to internal and external safety, quality, and regulatory standards for ATCC Federal Solutions. This role involves validating life science product processes across the entire lifecycle, from research and development to manufacturing and distribution for a key government contract.



  • Quality Assurance Protocol Development and Maintenance:
    • Develop, apply, revise, and maintain quality assurance protocols for processing materials.
    • Design procedures for inspecting, testing, and evaluating precision in production processes and finished products.
  • Compliance Management and Analysis:
    • Plan, implement, and manage compliance with safety, quality, and regulatory standards globally.
    • Assure adherence to specifications and standards like GLP, GMP, ISO, and Six Sigma.
    • Analyze production data, identify trends, and recommend updates to quality standards and procedures.
  • Validation and Auditing Activities:
    • Conduct routine review and approval of manufacturing equipment testing.
    • Collect, organize, and document test data, investigating and troubleshooting issues.
    • Maintain accurate records of validation activities, review and approve validation protocols and perform and/or support internal and external audits.


Education and Experience:

  • Bachelor's degree and 5 or more years' experience or equivalent experience.
  • Strong understanding of inspection, testing, and evaluation procedures for production processes and products.
  • Analytical mindset with the ability to analyze production data, identify trends, and recommend updates to quality standards and procedures.
  • Strong problem-solving skills for troubleshooting issues in validation and auditing activities.
  • Prior experience working with government preferred but not required.



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.
    • 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.
    • Exceptional career advancement opportunities, recognition, and rewards. 


Join ATCC, where we fuel your success, well-being, and development.  We're a mission focused non-profit Equal Opportunity Employer, championing diversity and inclusivity. When you work at ATCC, you become a part of that mission, one we've committed to for almost 100 years. Shape the future of science with us. 


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. 


ATCC is a private, nonprofit, global biological resource center and standards organization. We provide the scientific community credible biological products, advanced model systems, and high-quality services that support complex research in a variety of innovative applications resulting in incredible achievements in basic science, drug discovery, translational medicine, and public health.

We support the scientific community with the world’s largest and most diverse collection of human and animal cell products, as well as molecular genomic tools, microbe products, and biological materials. We offer a host of services, as well, including cell and microbial culturing and authentication, development and production of controls and derivatives, proficiency testing, and biomaterial deposit services. Through our ATCC Federal Solutions initiative, we lend our expertise to federal agencies in areas that include global health and infectious diseases, biodefense, and noncommunicable diseases.

We've developed a quality commitment, which includes ISO accreditations and standards, that has allowed ATCC to evolve from a traditional culture collection founded in 1925 to a biological resource center with an infrastructure that supports the future of life science and biotechnology.

Our newly expanded headquarters and bioproduction facility is located in Manassas, Virginia, near Washington DC, and a recently renovated research and technology center of excellence in Gaithersburg, Maryland.



Company info
10801 University Boulevard
United States

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