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Form of workQA Compliance Specialist III
Job ID: req3781
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
• Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. 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.
• May perform audits and risk assessments.
• Provides technical expertise and guidance in GMP compliance for Operations, QC, Validation, Manufacturing, and other departments as needed.
• Perform CSV reviews; Analytical Instrument Qualification (AIQ); Enterprise Systems Validation
• Perform reviews for HEPA filters, Pest control, equipment charts, SAS systems.
• Perform Return to Service (RTS) activities.
• Perform Validation reviews: Equipment, Performance Qualifications and Assay Validations
• Participate in Material Review Board meetings.
• Generates and reviews documents used in good manufacturing practices.
• Lead special project initiatives.
• Interprets FDA Guidelines and regulations from management.
• Participates in onsite audits as needed.
• Coordinates interdepartmental activities.
• Leads investigations and resolves potential product quality issues to improve efficiency as needed.
• Participates in risk assessments related to the QMS and regulatory observations; generates quality risk assessment reports; writes, revises, assists in writing, and reviews SOPs as needed.
BASIC QUALIFICATIONS
• Possession of a Bachelor of Science degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a chemistry, biochemistry, biotechnology, or other related area scientific related field or four (4) years relevant experience in lieu of a degree.
• Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have 5 years of experience.
• Must possess basic Microsoft Office skills.
• Experience with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs
• Experience with labeling operations of dispositioned material and the release of GMP materials.
• Experience with the GMP manufacture of Phase I/II clinical material.
• Experience with quality systems compliant with FDA regulations for cGMP.
• Experience in the review of test records, deviations, and change controls.
• Background in the release of incoming raw materials and components.
• Working knowledge of FDA and international biologics/drug regulations.
• Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources.
• Previous experience in GCP, GLP, or GMP regulated environment.
• Must be able to obtain and maintain a security clearance.
PREFERRED QUALIFICATIONS
Equal Opportunity Employer (EOE) Minority/Female/Disabled/Veteran (M/F/D/V) Drug Free Workplace (DFW)
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: req3781
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
• Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. 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.
• May perform audits and risk assessments.
• Provides technical expertise and guidance in GMP compliance for Operations, QC, Validation, Manufacturing, and other departments as needed.
• Perform CSV reviews; Analytical Instrument Qualification (AIQ); Enterprise Systems Validation
• Perform reviews for HEPA filters, Pest control, equipment charts, SAS systems.
• Perform Return to Service (RTS) activities.
• Perform Validation reviews: Equipment, Performance Qualifications and Assay Validations
• Participate in Material Review Board meetings.
• Generates and reviews documents used in good manufacturing practices.
• Lead special project initiatives.
• Interprets FDA Guidelines and regulations from management.
• Participates in onsite audits as needed.
• Coordinates interdepartmental activities.
• Leads investigations and resolves potential product quality issues to improve efficiency as needed.
• Participates in risk assessments related to the QMS and regulatory observations; generates quality risk assessment reports; writes, revises, assists in writing, and reviews SOPs as needed.
BASIC QUALIFICATIONS
• Possession of a Bachelor of Science degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a chemistry, biochemistry, biotechnology, or other related area scientific related field or four (4) years relevant experience in lieu of a degree.
• Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have 5 years of experience.
• Must possess basic Microsoft Office skills.
• Experience with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs
• Experience with labeling operations of dispositioned material and the release of GMP materials.
• Experience with the GMP manufacture of Phase I/II clinical material.
• Experience with quality systems compliant with FDA regulations for cGMP.
• Experience in the review of test records, deviations, and change controls.
• Background in the release of incoming raw materials and components.
• Working knowledge of FDA and international biologics/drug regulations.
• Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources.
• Previous experience in GCP, GLP, or GMP regulated environment.
• Must be able to obtain and maintain a security clearance.
PREFERRED QUALIFICATIONS
- Combination of QA and QC or manufacturing experience.
- Background in a functional discipline related to biologics (cell banking, upstream or downstream operations, validation, analytical testing, etc.).
- Demonstrated technical knowledge and knowledge of GMP, GLP, GCLP and GCP.
- The capability to contribute to cross-functional work, to present new ideas, assist other team members in number of areas.
- Must have the ability to clearly summarize and communicate compliance and quality issues to staff.
Equal Opportunity Employer (EOE) Minority/Female/Disabled/Veteran (M/F/D/V) Drug Free Workplace (DFW)
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
