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
II to join our team
in Gaithersburg, Maryland. The Sample Management
Technician II position is primarily responsible for specimen
handling,
including receipt, verification, accessioning and storage of
pre-clinical and
clinical samples. The work is performed in the
laboratory and requires both
sample handling and computer tasks.
Corporate
Responsibilities:
Adherence to laboratory health and safety
Adherence to Standard Operating Procedures
(SOPs)
Adherence to applicable company policies
and guidelines
Adherence to federal and/or local
regulations as applicable
Essential Position
Responsibilities:
Documents activities, records observations
and completes all paperwork in accordance with GLPs, SOPs,
and protocol.
Use established checklists in the routine
performance of task
Use, update and maintain sample management
tracking logs
Document sample discrepancies and
communicate to appropriate parties
Assures proper storage conditions for
sample types
Monitor proper storage of samples,
including appropriate location, temperature and condition of
freezers.
Participates in rotation for On-call
Freezer temperature monitoring
Prepares labels using automated and manual
systems
Process sample transfer requests, prepare
runs and consolidate samples for storage
Performs general sample management
laboratory support functions such as supply inventory,
shipping procedures,lab equipment (freezer) maintenance.
Performs freezer inventory/cycle counts
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
Performs end of day/Freezer closeout tasks
Ability to function effectively in a fast
paced, team-oriented atmosphere. Works independently when
necessary
Essential Position
Responsibilities In addition to SM Level 1:
Receive, check-in, verify and accession
study samples into LIMS according to established guidelines
and SOPs.
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
Identify and document all discrepancies
between client paperwork, LIMS, and sample vials
Responsible for training Sample Management
personnel (level 1)
Assists in Troubleshooting sample accession
related issues
Prepare sample disposition notifications,
ship, and dispose of study samples, under supervision
Recommend process improvements and/or
assist in revising SOPs/Forms
Ensure tasks are conducted in accordance
with study protocols, data transfer agreements (DTA), SOPs,
and other regulatory requirements
Assists in the interview process
Other duties as assigned and trained
Additional
Requirements
Sets an example of working safely with
potentially hazardous substances including blood born
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
Ability to multi-task and participate in
multiple studies concurrently
