QA Specialist II/III, Cell Therapy/Biopharmaceutical
October 10, 2023
QA Specialist II/III, Cell Therapy/Biopharmaceutical
Job ID: req3594
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.
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.
Assists and supports the organization with initial compliance monitoring of conformance to established quality assurance processes and standards for manufacturing and production of biopharmaceutical and cell therapy products. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures.
KEY ROLES/RESPONSIBILITIES (QA Specialist II)
The QA Specialist II:
KEY ROLES/RESPONSIBILITIES (QA Specialist III)
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.
#readytowork
Job ID: req3594
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.
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.
Assists and supports the organization with initial compliance monitoring of conformance to established quality assurance processes and standards for manufacturing and production of biopharmaceutical and cell therapy products. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures.
KEY ROLES/RESPONSIBILITIES (QA Specialist II)
The 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 from an accredited college or university according to the Council for Higher Education Accreditation (CHEA).. Foreign degrees must be evaluated for U.S equivalency
- In addition to the education requirement:
- Quality Specialist II: Minimum of 2 years related experience
- Quality Specialist III: Minimum of 5 years quality assurance experience in a GMP regulated environment (21CFR211, 21CFR606, and related)
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
- D emonstrated problem solving skills
- Ability to work in a team environment with minimal supervision to complete responsibilities
- Ability to communicate ideas clearly and effectively with all levels
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.
#readytowork