Biorepository Technician II

Precision Medicine Group, LLC.; Frederick, Northern (MD, KY); Hybrid; USD 26,000 - 36,000; Full time

Job summary

Precision Medicine Group, LLC is seeking a Biorepository Technician II in Frederick, MD to perform cryopreservation, receipt, and inventory of biological samples in a regulated lab.

You will reconcile data in the BSI, generate discrepancy reports, monitor freezers, comply with cGMP/cGLP/ISO procedures, and communicate clearly with sponsors and investigators.

Qualifications

• Basic laboratory skills and aseptic technique are required.
• Strong documentation and communication skills.
• Knowledge of IATA Shipping Regulations and certification maintenance.

Responsibilities

• Investigate and resolve data discrepancies with project collaborators.
• Prepare and analyze reports from the BSI to identify data errors.
• Verify discrepancies during withdrawal or inventory procedures.
• Complete investigations in specimen requisitions.
• Label vials and shipping boxes.
• Perform dry shipper QC and annual competency assessments.

Skills

Aseptic technique

Attention to detail

Documentation skills

Fluency in English

Education

High School Diploma or equivalent

2 years’ relevant work experience

Tools

Excel

BSI system

IATA Shipping Regulations knowledge

Job description

Location: Frederick, MD, USA
Category:
Division: Precision for Medicine
Business Unit: Translational Sciences
Requisition Number: 7169

Position Summary

The Biorepository Technician II will perform with a high degree of accuracy and quality a variety of laboratory-related activities including cryopreservation of biological samples that arrive daily in the repository. Must be skilled in data reconciliation and using the reporting features of the BSI. Experienced in written and verbal communications with either commercial clients or government investigators and a strong documentation background in a laboratory setting with respect to regulatory requirements (cGMP, cGLP or ISO) and Standard Operating Procedures is a requirement. Flexible team player who can change directions quickly and respond to a variety of Repository needs.

Essential functions of the job include but are not limited to

• Investigate and resolve data discrepancies in conjunction with project collaborators
• Prepare and analyze reports from the BSI to identify possible errors in data
• Verify discrepancies noted by Lab Technicians/Assistants during withdrawal or inventory procedures
• Complete Investigation tasks in specimen requisitions

Monitoring of freezers:

• Respond to freezer alarms in accordance with standard operating procedures
• Monitor freezers, refrigerator and room temperatures as assigned by Manager

Receive biological samples:

• Unpack specimens and record all pertinent information in Incoming Shipment Batch and incoming folder
• Create a folder to house all associated paperwork
• Store at appropriate temperature following guidelines set by procedures
• Distribute confirmation of shipment receipt form if required by project

Inventory of Frozen Biological Samples:

• Utilize Quality Control Vials to estimate volume of frozen samples
• Check information on sample vial against information provided by the study site
• Correct paperwork where necessary and inform supervisor/manager of any discrepancies by generating a discrepancy report
• Assist in the inventory of returned specimens
• Aliquot frozen specimens utilizing aseptic technique

Retrieve Frozen Samples from Inventory:

• Pull samples according to requisition, SOP, and instructions
• Perform quality control verification of outgoing samples
• Update Outgoing Batch Record
• Investigate missing specimens using the BSI and hardcopy data
• Contact receiving labs prior to shipment to confirm shipping address and ensure contact will be available to receive specimens
• Ship samples (dangerous and non-dangerous goods) by Commercial or local courier
• Complete all paperwork (background forms, link-up forms, aliquot forms, return forms or BSI data collection sheets and any other forms which may be necessary)
• Perform annual competency assessments for Repository staff
• Label vials and shipping boxes
• Perform dry shipper QC
• Coordinate and execute the quarterly temporary freezer inventory
• Coordinate Repository Equipment preventative maintenance
• Keep current on IATA Shipping Regulations and maintain certification and standards
• Carry out other duties/projects as assigned

Qualifications

• High School Diploma or equivalent combination of education and experience
• 2 years’ relevant work experience

Other required:

• Must possess basic laboratory skills and be trained in aseptic technique
• Current knowledge of IATA Shipping Regulations and maintenance of certification and standards
• Comfortability with excel and its functions, as well as BSI
• Requires good attention to detail, excellent documentation skills and must work well in a group environment
• Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignment and changing business needs
• Ability to lift and carry between 31-50 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, stand and walk for prolonged periods; occasionally required to squat, bend, stoop, push, kneel, reach and perform tasks with repetitive motion; Will be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
• Must be able to read, write, speak fluently and comprehend the English language

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

Reasonable estimate of the current range

$19— $26.30 USD

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail] .