QA Specialist II/III
November 15, 2022
QA Specialist II/III
Job ID: req2725
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 a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.
Position Overview:
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)
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Job ID: req2725
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 a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.
Position Overview:
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)
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork