QA Specialist II/III
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Frederick, MD
- Start date
- Oct 22, 2021
View more
- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
PROGRAM DESCRIPTION
The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports 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
QA Specialist II
- 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
- Assists others in writing SOPs and other documents
- Contributes to quality training development
- Prepares supporting documentation for release of products
- Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)
- Participates in team meetings
QA Specialist III
- 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
- 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 trendingParticipates 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
- QA Specialist II- In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
- QA Specialist III- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
- Assurance experience in a GMP regulated environment (21CFR211, 21CFR606, and related)
- 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
- 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, GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products
- Experience with Quality System Management
- 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
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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