cGMP Coordinator

Job ID: req2466
Employee Type: exempt full-time
Division: Vaccine Clinical Materials 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 Director, cGMP Facility, the cGMP Coordinator will perform various administrative and clerical duties to support the operations of the facility maintenance & engineering department. The cGMP Coordinator will:

• Be the POC for the VPP for equipment Request for Vendors Service Requests (RVS) ensuring they are put into the system; help the client determine the required service level; work with the client to complete JOFOCs as needed; request vendor quotes; track the RVS progress through the system; approve the invoices; ensure the invoices are closed in a timely manner
• Be the POC for VPP Maintenance Service Agreements (MSA) ensuring requests for service is charged appropriately; ensure the agreements are renewed in a timely manner; run reports when requested; provide estimated costs to administration when needed; add/remove equipment from MSAs when requested
• Schedule preventive maintenance service requests as needed
• Assist the client with surplusing equipment as needed
• P erform duties associated with assisting the current RAM administrator such as set up assets in the software, issue VPP tracking numbers, set up and track scheduled PMs, review SOPs against schedules to maintain full compliance, update work and REQs as needed, scan service reports as needed, updating RAM users in the system, updating RM asset and personnel records as needed, providing RAM reports and status for all facilities staff
• Backup the current Spec I, Bldg Coordinator as required by tracking spare parts inventory, maintain new stock items in storage areas, obtain quotes, prepare material purchase forms to replenish stock, update/maintain spare parts tracking file, perform semiannual physical inventory
• P lans facilities changes for plant, office, and production equipment layouts, working toward economy of operation, maximum use of facilities and equipment and compliance with laws and regulations
• Helps develop criteria and performance specifications for facilities and equipment required to meet unique operating requirements and building and safety codes
• Schedules preventative maintenance (PM) and repairs with vendors for facilities group
• Coordinate closely with all departments to manage required PM service and repairs
• Assist with property inventory and surplus requests
• Receive, log, and schedule work orders for maintenance within the Pilot Plant
• Assist with administrative functions including supply ordering, coordinating work orders, and equipment inventory and maintenance
• Track activities of and coordinate interactions with preventive maintenance subcontractors
• Track instruments sent out for calibration and manage all associated paperwork
• Interact with ALS personnel regarding the status of various subcontracts
• Assist with stored equipment tasks for 7114 warehouse (surplus paperwork, equipment delivery, etc.)
• Complete pre-shipping forms and submit for approval
• Review QA status spreadsheets (showing Corrective Actions, Deviations, Change Controls) and track/highlight due dates for FME team
• Record training in Success Factor and Content Server
• Communicate with executive, administrative and line management personnel to gather or convey information
• Manage calendar, schedule, and prioritize appointments, ensuring meetings, deadlines, presentations, and other duties are carried out seamlessly
• Type, review and edit correspondence, memoranda, reports, and other documents
• Participates in planning functions

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience four (4 years) administrative experience in an office or facility maintenance & engineering environment may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• No experience required beyond education requirement
• Working knowledge and/or demonstrated ability to follow established policies and procedures, Good Documentation Practices and Good Manufacturing Practices (GMP) regulations/requirements
• Experience scheduling appointments, compose and type correspondence, gather, and summarize data, prepare reports, arrange meetings, schedule work, and coordinate the work of several units effectively
• Knowledge of office practices and procedures including a high degree of specialized knowledge in administrative areas
• Highly proficient in MS Office (e.g., Outlook, Word, Excel, Teams and PowerPoint) with ability to learn new software systems when necessary
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• A minimum of two (2) years' experience assisting in the planning of preventative maintenance, repair, and work order activities
• Experience in Blue Mountain Regulatory Asset Manager (RAM)
• Experience in Cost Point
• Experience in SharePoint
• Experience writing SOP's, change controls and deviations in a cGMP environment
• Strong organizational and time management skills that reflect ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail and accuracy
• Ability to effectively organize work priorities and complete assigned duties with minimal supervision
• Effective interpersonal and communication skills (verbal and written); able to interface with personnel at all levels

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

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