QA Specialist Lot Release

Job ID: req3917
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.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• May perform audits and risk assessments.
• Review documentation associated with Contract Manufacturing Organization (CMO) materials, including, but not limited to, batch records, testing records, deviations, and change controls.
• Review and approve product specific documentation including but not limited to stability reports, product specifications, batch records, testing records, deviations, and change controls.
• Review and approve lot release related change controls.
• Coordinate room release activities for the production of GMP material.
• Coordinate QA on-the-floor (OTF) operations.
• Participate in Material Review Board meetings.
• Provide lot release reports on a routine basis to QA management.
• Lead special project initiatives.
• Revise SOPs for process improvements.
• Participate in meetings to support lot release activities as required.
• Participate in product shipments to clinical sites.

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 quality assurance, biology, chemistry, biochemistry, or pharmaceutical technology in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of progressively responsible job-related experience in a GMP environment.
• Must possess basic Microsoft Office skills.
• 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.
• Experience with quality systems compliant with FDA regulations for cGMP.
• Experience in the review of test records, deviations, CAPAs, and change controls.
• Ability to clearly summarize and communicate compliance issues to staff.
• Experience with room release activities for the production of GMP material.
• Experience with the review of GMP processing batch records (PBRs).
• Experience with the release of GMP materials.
• Experience with the GMP manufacture of Phase I/ II clinical material.
• Working knowledge of quality systems.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Combination of QA and QC or manufacturing experience.
• Working knowledge of LIMS and MasterControl.
• Background in a functional discipline related to vaccine and biologics is a plus (cell banking, upstream or downstream operations, validation, analytical testing, etc.)
• Experience with AQL vial inspections.
• Experience with QA on the floor operations during production of GMP material.

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

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.
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