QA Lot Release Manager I in Frederick, MD

Description

QA Lot Release Manager I

Job ID: req1548
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

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 other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

Reporting to the Manager, QA Lot Release and Regulatory Affairs, will manage the QA lot release group and perform tasks consisting of, but not limited to, the following:

• Supervise at least five (5) QA Lot Release Specialists
• Conduct employee performance reviews and approve employee leave and timesheets
• Participate in onsite audits as required
• Review internal and Contract Manufacturing Organization (CMO) documentation including, but not limited to, batch records, testing records, deviations, and change controls
• Review and approve product specific documentation (e.g., stability reports, product specifications, component specifications)
• Approve lot release related change controls and deviations
• Manage room release activities for the production of GMP material
• Manage 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
• Manage and the development of SOP revisions for process improvements
• Participate in meetings to support lot release activities as required
• Interact with senior management
• Manage the release of incoming raw materials and components
• Coordinate the QA review of released drug product shipments to clinical sites

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college or university in scientific discipline according to the Council for Higher Education Accreditation (CHEA) in a related field 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 four (4) years job related experience
• Two (2) years experience in a lead or supervisory role 
• Experience with labeling operations 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
• Ability to clearly summarize and communicate compliance issues to staff
• Background in supplier management associated with 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
• Working knowledge of Microsoft Office
• Previous experience in GCP, GLP, or GMP regulated environment
• Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

• Candidates with these desired skills will be given preferential consideration
• Combination of QA and QC or manufacturing experience
• Working knowledge of quality systems with the GMP manufacturing of Phase I/II clinical material
• Background in a functional discipline related to biologics (cell banking, upstream or downstream operations, validation, analytical testing, etc.)

JOB HAZARDS

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

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

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