Lab Documentation Specialist - NIH

Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide an up-to-date resume.

Responsibilities.

• Manage and provide oversight for scientific and regulatory-supporting documentation systems for a diverse group of 100 scientists and administrative staff.
• Oversee general documentation systems and policies.
• Ensure, via policy development and liaising with VPP management and staff, that all documents meet pharmaceutical industry equivalent writing standards.
• Design and provide training to VPP staff on current writing and grammar standards.
• Provide grammatical and formatting review of technical document sand forms, as needed.
• Identify documentation system gaps and work with VPP management to design and implement solutions.
• Periodically review current VPP documentation system for areas of improvement.
• Manage and oversee the Electronic Document Management System(s)(EDMS), and SharePoint, including, but not limited to:
  • Serve as the main point of contact for EDMS document requests.
  • Serve as the EDMS Subject Matter Expert or SME, proving technical support to VPP staff.
  • Design and provide EDMS training to staff.
  • Ensure EDM Straining records are adequately maintained.
  • Ensure all VPP documents are stored and managed in the EDMS system properly.
  • Support cross functional teams with creation, revision, approval or obsoletion of all documents processes within EDMS.
  • Track requests and progress through the EDMS review process and communicate with all affected stakeholders as needed.
  • Maintain EDMS standard work instructions (SOPs), training and reference materials.
  • Maintain document archives.
• Oversee the VPP storage and retrieval of laboratory notebooks.
• Oversee archiving of all job-related documentation (notebooks, training records, etc.). of departing personnel.
• Stay current on NIH and Federal documentation archival guidelines to ensure current and new documentation systems are in compliance.
• Develop and implement departmental policies related to primary duties and other aspects of VPP Scientific Operations as needed.
• Follow established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
• Perform miscellaneous job-related duties as assigned including but not limited to performance of property checks, maintenance of service contracts on lab equipment and monitoring inventory levels.
• Serve as a primary or backup emergency responder for all VPP REES monitored equipment.
• Represent Scientific Operations group at safety meetings as needed.
• Operate dolly/ pallet jack in loading and unloading supplies and equipment.
• Maintain consumable inventory stock for VPP process’.
• Perform inventory assessments/procurements, development of tracking systems, and equipment systems monitoring.
• Obtain purified bulk vaccine candidates/biotherapeutics or bioreagents from the Vaccine Production Program (VPP) downstream group.
• Verify all label information on the bulk from downstream is correct.
• Determine the aliquoting plan for each lot of bulk received per direction of the scientific operations manager for VPP.
• Generate the correct number of labels per container size for each lot.
• Perform the aseptic aliquoting for each lot of bulk in a biological safety cabinet.
• Determine the storage location for each aliquoted lot (-80C, -30C,or 4C) as specified by either the scientific operations manager or the project manager for the VPP.
• Liaise with VPP, VRC and external stakeholder personnel on receipt and distribution of above materials, including communication and documentation systems.
• Verify VPP produced materials are properly entered into the materials database.
• Maintain real-time inventory records, including storage conditions and location of above materials.
• Ship and receive above materials, including preparing shipments for postal or commercial conveyance; selecting appropriate shipping container; packing items to ensure safe delivery; preparing bills of lading; checking items to be shipped against work orders to ascertain that quantities, destination, and routing are correct.
• Maintain the 9WW waste room in accordance with MOCO, MDE, and Federal guidance.
• Remain current with all changes in hazardous communications and regulations in accordance with shipping, handling and removal of biological and chemical compounds.
• Follow and stay current on all IATA/USDOT/ and RCRA guidance for shipment of biological and chemical materials.

Qualifications.

• Master’s degree in scientific or medical field is required.
• Minimum of 4 years of biological materials handling experience, with emphasis on maintain sterility and preservation of biological materials.
• Minimum 6 years’ experience managing scientific controlled document systems, in a scientific or clinical environment.
• Experience administering electronic controlled document systems.
• Thorough knowledge of document change control processes.
• Extensive experience in using computer software used for document management, formatting, editing, and archiving, including but not limited to, Microsoft Word and Adobe PDF creation, editing, and fillable form preparation.
• Thorough knowledge of professional grammar, writing, and editing practices.
• Knowledge of AMA or similar style guidance’s.
• Knowledge of general technical and/or scientific documentation classes and content requirements, such as standard operation procedures, investigative reports and other procedural document.
• Experience with conversion of hardcopy records to electronic format.
• Individual must have excellent verbal and written communication skills (English).
• Individual must demonstrate the ability to communicate clearly and professionally.
• Demonstrated ability, per previous experience, to work independently.
• Proactive in the identification of organizational needs and/or problem areas within the scope of the position.
• Proactive problem solver.
• Highly skilled oral and written communicator o Able to effectively present and communicate information to a diverse group of colleagues.
• Able to address questions in a professional and constructive manner.
• Ability to apply professional experience and exercising good judgment in interpreting guidelines for specific situations and creativity in recommending new or modified procedures and products when needed.

Benefits.

• Medical, Dental, & Vision Coverage
• Paid Time Off and Paid Holidays
• 401K/Profit Sharing Plan
• Flexible Spending Accounts (Healthcare & Dependent Care)
• Pretax Parking & Transportation Plan
• Short-Term & Long-Term Disability Insurance
• Life & AD&D Insurance
• Professional Development/Education
• Employee Referral Bonuses
• Employee Discount Program
• Merit Bonuses
• Employee Assistance Program
• Travel Assistance Program

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.