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GLP Archivist/Lab Manager

Location
Frederick, MD

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Job Details
Description
ICON Government and Public Health Solutions (a trade name of **MEMBERS ONLY**SIGN UP NOW***., Inc.) specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.
ESSENTIAL FUNCTIONS:
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Archiving and retrieval of all data (including e-data) generated from the conduct of non-clinical studies in accordance with the Food & Drug Administration Good Laboratory Practice (GLP) and other applicable regulations; storage and retrieval of all study data in accordance with GLP and governing Standard Operating Procedures (SOP).
Establish effective communications with Study Directors, Quality Assurance and other key study personnel.
Ensure that all electronic and paper raw data, documentation, protocols (including amendments/deviations), final reports and samples collected from the study are retained in accordance with the approved protocol and GLP regulations.
Ensure that test and control articles used on non-clinical studies are appropriately inventoried and retained in accordance with the approved protocol and GLP regulations.
Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during a FDA inspection.
Ensure that storage conditions are maintained to prevent deterioration of documents or samples for the duration of their retention. At the request of the Sponsor, the Records Manager/Archivist will coordinate the transfer of study data/samples to off-site archival locations, if required.
Ensure that only authorized personnel have access to the archive in accordance with governing SOP GLP regulations.
Ensure that materials retained in the archive are appropriately indexed to permit expedient retrieval.
Ensure that records, raw data and samples are retained in accordance with the protocol and/or applicable FDA GLP regulations.
Maintain the Non Clinical Development (NCD) laboratory to the standards of GLP, applicable safety requirements and USAMRIID Regulations and SOPs: clutter free; clean; labeled reagents and solutions; expired materials removed; equipment and instrument documentation maintained; alarm jack testing performed, maintain emergency “on call list’ for multiple storage units, monthly laboratory safety inspection performed/reported, weekly eyewash/drain logs/ insect trap checks, weekly temperature chart changes performed and documented, and assure all chemicals and reagents are properly stored.
Monitor electronic data for multiple temperature and humidity storage equipment devices and laboratories will be downloaded, maintained on a secured drive for user access and archived on a scheduled basis IAW USAMRIID SOPs.
Receive, store, inventory maintain and document Test specimens (TSS-test sample sets) (~60/year) in accordance with USAMRIID SOPs.
Receive, store, inventory, maintain and document RMR (Reference Material Receipt) items in accordance with USAMRIID SOPs.
Receive, store, inventory, maintain and document Test and Control Articles, in accordance with USAMRIID SOPs.
Receive, inventory and store routinely used supplies into assigned buildings in addition to keeping assigned laboratory areas well stocked. Assist with storage and inventory of study specific supplies, thereby working with the study team to verify items are available when needed.
Ensure that dirty glassware will be rinsed and transferred to appropriate areas for cleaning and trash receptacles (biohazard, sharps, paper). Transfer glassware from assigned buildings such that applicable laboratories areas are sufficiently stocked.
Accompany QARCO, Sponsor and regulatory auditors, safety inspectors, and maintenance personnel during inspections and equipment maintenance/repair. Ensure that audit responses are addressed and inspection findings are corrected in a timely manner IAW USAMRIID SOPs.
Prepare work orders and small equipment items to be sent out for calibration, delivered to EMD and picked up once service has been completed.
Archive equipment records.
Update and generate new SOPs as assigned.
Provide hands-on laboratory safety training for new employees.
Maintain a safe workplace ensuring awareness and observation of appropriate safety and occupational health rules and regulations.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
Qualifications
Education
Required
Bachelors or better in Biology or related field.
Experience
Required
Demonstrated knowledge and experience in record/data management and archiving
GLP experience
Must be a US citizen
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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