Biopharmaceutical QA Specialist III
Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: January 28, 2026
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Job Description:
Biopharmaceutical QA Specialist III Job ID: req4463 Employee
Type: exempt full-time Division: Biopharmaceutical Development
Program Facility: Frederick: ATRF Location: 8560 Progress Dr,
Frederick, MD 21701 USA The Frederick National Laboratory is
operated by Leidos Biomedical Research, Inc. The lab addresses some
of the most urgent and intractable problems in the biomedical
sciences in cancer and AIDS, drug development and first-in-human
clinical trials, applications of nanotechnology in medicine, and
rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity
and Versatility; it's the FNL way. PROGRAM DESCRIPTION The
Biopharmaceutical Development Program (BDP) of Leidos Biomedical
Research, Inc. supports the Frederick National Laboratory Cancer
Research (FNLCR) and other government agencies through the
development of novel agents for first-in-man clinical studies. KEY
ROLES/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 BASIC QUALIFICATIONS To be considered for this
position, you must minimally meet the knowledge, skills, and
abilities listed below: 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 QUALIFICATIONS Candidates with these desired
skills will be given preferential consideration: 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 JOB HAZARDS
This position is subject to working with or have potential for
exposure to infectious material, requiring medical clearance and
immunizations. Commitment to Non-Discrimination All qualified
applicants will receive consideration for employment without regard
to sex, race, ethnicity, color, age, national origin, citizenship,
religion, physical or mental disability, medical condition, genetic
information, pregnancy, family structure, marital status, ancestry,
domestic partner status, sexual orientation, gender identity or
expression, veteran or military status, or any other basis
prohibited by law. Leidos will also consider for employment
qualified applicants with criminal histories consistent with
relevant laws. Pay and Benefits Pay and benefits are fundamental to
any career decision. That's why we craft compensation packages that
reflect the importance of the work we do for our customers.
Employment benefits include competitive compensation, Health and
Wellness programs, Income Protection, Paid Leave and Retirement.
More details are available here 76,800.00 - 110,103.00 USD The
posted pay range for this job is a general guideline and not a
guarantee of compensation or salary. Additional factors considered
in extending an offer include, but are not limited to,
responsibilities of the job, education, experience, knowledge,
skills, and abilities as well as internal equity, and alignment
with market data. The salary range posted is a full-time equivalent
salary and will vary depending on scheduled hours for part time
positions
Keywords: Frederick National Laboratory for Cancer Research, Bethesda , Biopharmaceutical QA Specialist III, Science, Research & Development , Frederick, Maryland
