Smithers - Medical Device Testing · 13 hours ago
Sample Management Technician
West Trenton, NJ
Full-time
Onsite
New Grad, Entry Level
$20/hr - $23/hrSmithers PDS LLC is a company that provides pre-clinical and clinical services for drug development. They are seeking a Sample Management Technician responsible for receiving, storing, and disposing of study samples while ensuring proper documentation and reporting of discrepancies.
AnalyticsBiopharmaBiotechnology
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
Performs general sample management laboratory support functions such as supply inventory, shipping procedures, lab equipment (freezer) maintenance
Other duties as assigned and trained
Qualification
Required
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
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
Ability to function effectively in a team-oriented atmosphere
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
Benefits
Comprehensive health insurance package including a choice of 3 medical plans
Dental insurance
Vision insurance
401K retirement plan
PTO
Company
Smithers - Medical Device Testing
Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant, and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in Europe, the UK, and the USA.
Founded in 2009
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$0.62M2010-01-05Seed· $0.62M
Leadership Team
Zoe Lambert
Sr.HR Business Partner
Company data provided by crunchbase