Senior Quality Assurance Engineer

OverviewReady 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. Responsibilities

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.

QualificationsEducation 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.

ATCC Mission:

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.

Job LocationsUS-MD-GaithersburgRole Type Onsite Department Quality Control Job ID 2023-3673