QA Specialist II/III (req2024)
Company: Frederick National Laboratory
Location: Frederick
Posted on: October 13, 2021
Job Description:
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
Keywords: Frederick National Laboratory, Frederick , QA Specialist II/III (req2024), Other , Frederick, Maryland
Didn't find what you're looking for? Search again!
Loading more jobs...
