QA Specialist (cGMP Audit Program)

Job ID: req2709
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

Reporting to the QA Manager, Supplier Management, the QA Specialist will:

• Assist and support the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production
• Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
• Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them
• Facilitate internal training on quality assurance requirements, processes, and procedures
• May perform audits and risk assessments
• Assist with supplier audits on a regular basis to ensure suppliers and their supplies remain in compliance with company and federal manufacturing and production standards
• Assist with remote and onsite audits
• Communicate with suppliers regularly to address any concerns, improve performance, and foster an environment that facilitate continual improvement in working relationships
• Communicate with departments regularly to address any concerns, improve performance, and foster an environment that facilitates continual improvement in working relationships
• Perform investigation and analysis of supplier corrective actions and notification of changes
• Understand and interpret regulations and standards as it relates to (i.e., including 21 CFR part 11, 58, 210/211, 606, ISO 9001, and 17025) Support Third Party inspection
• Participate in the generation and review of new and revised documents (i.e., SOPs, MBR, TMs, and other cGMP critical support documents)
• Participate in the generation of trending key indicators (i.e., Supplier Corrective Actions, Effectiveness Checks, Open Audits)

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
• In addition to the education requirement, a minimum of two (2) years related experience
• Knowledge of or experience in cGMP, API (Active Pharmaceutical Ingredient) drug development, Auditing, and Inspection Management; developing Material release and qualification systems and developing Quality Agreements (internal/external customer and supplier relationships)
• Experience in performing external audits
• Working knowledge of Microsoft Office
• Experience in GMP-regulated industries
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• 2 years experience in Quality Assurance
• Working knowledge of quality systems
• Working knowledge of review, inspection, and disposition of all incoming materials
• Experience with the GMP manufacture of Phase I/II clinical material
• Strong interpersonal skills with the ability to communicate with suppliers, customers, and individuals at all levels of the organization in a clear, focused, and concise manner
• Self-directed with the ability to work independently
• Ability to clearly communicate with team members and upper management
• Ability to travel 25%

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

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