Frederick National Laboratory for Cancer Research · 5 days ago
Biopharmaceutical QA Specialist III
Frederick, MD
Full-time
Onsite
Senior Level
$77K/yr - $110K/yr
5+ years expThe Frederick National Laboratory for Cancer Research is operated by Leidos Biomedical Research, Inc., focusing on urgent biomedical science problems. The Biopharmaceutical QA Specialist III role involves supporting management in implementing the Quality Management System and conducting reviews and audits to ensure compliance with specifications and regulations.
BiotechnologyHealth CareMedicalOncology
Responsibilities
Supports management in the implementation of the Quality Management System
Reviews batch records and test results for completeness, accuracy and conformance to specifications
Reviews and releases raw materials for conformance to specifications
Performs in-process audits of manufacturing, analytical, and other activities
Performs area clearance activities
Assists with Quality Management System process audits
Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions
Assists in the identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.)
Assists with audits from regulatory bodies and external customers
Contributes to process improvement projects and /or is accountable to lead assigned projects
Writes SOPs and other documents
Identifies and supports management of change (MOC) in the quality system
Assists in developing providing quality training
Prepares supporting documentation for release of products
Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)
Supports management in the collection and trending of Key Performance Indicators (KPIs) and trending
Participates in team and project meetings
Qualification
Required
Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
Experience within a GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products
Experience with Quality System Management
Ability to obtain and maintain a security clearance
Preferred
Experience in a Phase I/II clinical trial
Quality Specialist III must have demonstrated problem solving skills
Ability to work in a team environment with minimal supervision to complete responsibilities
Must be able to communicate ideas clearly and effectively with all levels
Education or experience in a STEM environment
Benefits
Health and Wellness programs
Income Protection
Paid Leave
Retirement
Company
Frederick National Laboratory for Cancer Research
Frederick National Laboratory for Cancer Research specializes in developing biomedical research and technology to improve human health.
1001-5000 employees
H1B Sponsorship
Frederick National Laboratory for Cancer Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (17)
2023 (25)
2022 (23)
2021 (32)
2020 (28)
Funding
Current Stage
Late StageLeadership Team
Amanda Brooks
Talent Acquisition Partner
Betsy Day
Learning and Development Partner
Recent News
2025-10-14
2025-09-29
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