Job Details - QA Specialist - 43281401 | Frederick National Laboratory Talent Network
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QA Specialist II/III in Frederick, MD

Location: Frederick, MD
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

PROGRAM DESCRIPTION
The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

The Biopharmaceutical Development Program offers resources for and expertise in the development of investigational biological products that move promising treatments for cancer, rare diseases, AIDS, and infectious diseases into clinical trials.  This includes personalized cell therapy treatment. 

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

KEY ROLES/RESPONSIBILITIES  (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 trending
Participates in team and project meetings


BASIC QUALIFICATIONS
Bachelor's degree for an accredited college or university. Foreign degrees must be evaluated for U.S equivalency
Quality Specialist II will have 2-5years of experience Quality Specialist III a minimum of 5 years quality 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

PREFERRED QUALIFICATIONS
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

EXPECTED COMPETENCIES: (Only if the Survey Job Title indicates any expected competencies, is this information required.)

JOB HAZARDS/VACCINATION REQUIREMENTS:  Employee would receive required and determined by Occupational Health Services (OHS) and/or mandated by Federal Health Standard Regulations.

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)


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