Sample Management Technician

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.

Smithers PDS LLC (Pharmaceutical Development Services) is seeking a Sample Management Technician to join our team in Ewing, New Jersey. The Sample Management Technician is responsible for the receiving, storing and disposing of study samples. The role is also responsible for documenting and reporting any discrepancies.

Essential Position Responsibilities

• Reviews laboratory workload and prepares schedules in conjunction with Laboratory Manager and SM Supervisor.
• Documents activities, records observations and completes all paperwork in accordance with GLPs, SOPs, and protocol.
• Receive, check-in verify, and accession of study samples into Watson LIMS according to established guidelines and SOPs.
• Use established checklists in the routine performance of task.
• Use, update and maintain sample management tracking logs.
• Identify and document all discrepancies between client paperwork, Watson LIMS, and sample vials.
• Generate discrepancy reports and notifies PMs, sponsor/relevant parties of the discrepancies. Follows up to obtain resolution in a timely manner.
• Assures proper storage conditions for sample types.
• Monitor proper storage of samples, including appropriate location, temperature and condition of freezers.
• Performs freezer inventory/cycle counts.
• On-call for REES Freezer monitoring.
• Prepares labels using automated and manual systems.
• Verifies transfer requests, create run boxes/stage runs and re-file analyzed samples to permanent location
• Accessions specimens using automated and manual systems.
• Use Watson LIMS to set-up shipments and receive shipment samples.
• Use Watson LIMS to edit subject ID information and assign custom IDs.
• Assists in Troubleshooting sample accession related issues.
• Prepare sample disposition notifications and dispose of study samples.
• Reviews study protocol and ensure study tasks and data for studies are conducted in accordance with established protocols, SOPs, GLPs, and other pertinent regulatory requirements.
• Notifies PI/PM and sponsor of sample quality issues and documents appropriately.
• Ability to function effectively in a team-oriented atmosphere. Works independently when necessary.
• Recognizes deviations from normal situations and results, resolves problems within area of expertise, and informs supervisor when the problem is outside of their scope, experience or authority.
• Responds to client/QC/QA audits and documents deviations.
• Recommends process improvements and/or assists in revising SOPs/Forms.
• Assists in training Sample management personnel.
  
  

Additional Position Responsibilities

• Performs general sample management laboratory support functions such as supply inventory, shipping procedures, lab equipment (freezer) maintenance.
• Other duties as assigned and trained.
  
  

Education And Experience Requirements

• High School diploma
• Attention to detail
• Organized
• Must be able to work overtime as needed
• Participate in on-call schedule
• Familiar with basic computer applications such as Microsoft Outlook, Word and Excel
  
  

Additional Requirements

• Sets an example of working safely with potentially hazardous substances including bloodborne pathogens. Practices universal safety precautions and wear appropriate personal protective equipment.
• Ability to produce high quality data while working under the pressure of strict deadlines.
• Excellent written and oral communication skills.
• Ability to multi-task and participate in multiple studies concurrently.
• Overtime, weekend, and holiday work as required.
• Participates in afterhours on call list as required
• Schedule: 9:00AM to 5:30PM
  
  

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