Ref No.

CLL-CO-2021

Location

US ~ Miami

Lab Lead

Company Overview

Our growing and successful business comprises of over 850 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

The Role

  • Overall responsibility for quality of laboratory processing for assigned duties
  • To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual
  • To ensure subject safety at all times

Main Tasks and Responsibilities:

  • Provides encouragement, support, positive reinforcement to laboratory technicians
  • Oversees sample labelling, processing and shipping duties as required
  • Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis
  • Processes biological samples as per lab manual when required
  • Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies
  • Reviews/Approves lab manual prior to the start of a study
  • Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline
  • Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments
  • Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs
  • Ensures the QC of laboratory source data and performs QC as necessary
  • Works in a safe and responsible manner at all times
  • Reviews protocol specimen processing requirements and ensures a sufficient quantity of necessary supplies are available or ordered and delivered prior to study start
  • Ensures adequate inventory of lab supplies prior to study start and throughout study conduct
  • Reviews/approves specimen labels prior to tube preparation
  • Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection
  • Processes samples and assists with laboratory duties as needed
  • Assists with SOP reviews and edits
  • Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits
  • Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study
  • Assists in any other duties as assigned

The Candidate

  • Laboratory / Sample processing experience essential
  • Education or equivalent experience in a science, health or customer related field
  • Supervisory experience preferred

The job may involve the following:

Very high concentration of work
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Working in a hazardous environment with high requirement to follow safety procedures
Working outside normal working hours
Needing to respond to client demands

Company benefits

In return you will receive a competitive salary, excellent training and development, as well as an exciting career within a fast paced and dynamic business.