Overview:
Must be a US Citizen or Green Card holder
W2 with full benefits
Offer contingent on ability to successfully pass a background check and drug screen
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Management Analyst to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term position which offers:
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Competitive salary
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Tremendous growth opportunity
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Opportunity to work at NIH, the world's foremost medical research center
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Learn more about what Columbus can do for you at www.columbususa.com
The US base pay rate for this full-time position is $65.67hr + benefits. Salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
Responsibilities:
This position will independently provide support services to satisfy the overall operational objectives of the NCI/CCR.
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Work with the TIL Lab manager and the regulatory project staff in the SurgeryBranch Protocol Support Office to initiate a revised QA plan to maintain compliance with cGMP.
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Gather and analyze information about processes and programs; prepare reports, letters, and other documents for review and input for programs, policies, and activities.
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Update and develop content for databases and monitor for currency and accuracyof information entered.
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Initiate training schedule of new TIL Lab personnel.
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Provide intranet updates and changes.
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Coordinate the printing and conversion of paper documents to electronic files.
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Update/maintain shared calendars.
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Coordinate meetings, workshops and courses for staff; schedule conference rooms.
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Maintain office records including office procurements and reimbursement information.
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Track, record and send manuscripts to reviewers.
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Prepare documents for the Annual Report to the FDA for BB MF 13871
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Prepare documentation for quadrennial site visits.
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Prepare documentation and locate documents for internal and external audits.
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Prepare reports on internal and external audits.
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Gather, compile, analyze and prepare justifications for administrative requests, such as procurement (POTS) and training (NIHITS) requirements; input requests into administrative databases.
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Coordinate the day-to-day office operation, including, but not limited to problem and conflict resolution, organization and prioritization of tasks; respond to written communications.
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Serve as liaison in the Surgery Branch cGMP group (VPF, QC, CPF) to coordinate and maintain the document management database required for cGMP compliance 3
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Design and coordinate systems for communications among staff to facilitate the efficient flow of information relating to projects and program activities; conveyCell Project Scheduling assignments to members of the clinical team.
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Note commitments made by executive level during meetings and arrange for staff implementation.
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Work with clinical staff and TIL Lab staff to arrange for reagents and time sensitive materials to be procured and delivered to the TIL Lab during the time critical window during cell product production.
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Maintain inventory of time-critical, short shelf-life supplies and reagents used in the production of Adoptive T-cell Therapy (ACT) products for patient treatment.
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Place orders, work with vendors and NIH purchasing to implement more efficient means of ordering, tracking and payment.
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Schedule and facilitate maintenance and calibration of equipment as required by GMP.
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Coordinate document and record tracking including SOPs, training records and calibration records to ensure compliance with GMP.
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Process document management system ensuring version updates of critical manufacturing documents including Policies, SOPs, Trainings and Batch Records.
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Coordinate staff training programs ensuring all personnel requisite training is current.
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Schedule pick up for all samples being shipped from the TIL Lab; ensure that required documentation is in place prior to shipping.
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Review outgoing correspondence for executive level’s approval and alert writers to any conflict with the regulations or departure from policies or executive level’s viewpoints; make recommendations to resolve problems that arise.
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In the executive level’s absence ensure that requests for action or information are relayed to the appropriate staff; decide whether executive level should be notified of important or emergency issues.
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Brief the Chief on status on reagents and critical materials to be considered at weekly and branch level meetings and conferences.
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Review and summarize the status of critical supplies and materials on a weekly basis; coordinate with clinical team and supervisor to create patient treatment schedule-based patient need as determined by the clinical staff and availability of critical materials.
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Compose correspondence requiring some understanding of technical matters within the program.
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Develop, maintain and update databases for the following:
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Develop, maintain and update databases for Personnel training
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Develop, maintain and update databases for SOP generation and review
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Develop, maintain and update databases for Batch Record filing and archiving
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Develop, maintain and update databases for Maintenance and calibration of medical/scientific equipment
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Tracking production records including deviations to determine the need for revisions of SOPs
Qualifications:
- Master's Degree in General Business or related field
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2 years specialized experience
plus BA/BS degree -
MS office experience
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Excellent analytical, organizational and time management skills
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Strong verbal and written communication skills
