Lab Training Specialist

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QPS’ Story:

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

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The Job

The Senior Specialist, Lab Trainer is a junior member of the Training (TRN) support unit within the Department of Translational Medicine (TLM) and is responsible for all daily activities that support the smooth operation and regulatory compliance of TLM. This is a non-production, oversight role.

The Senior Specialist Lab Trainer is an individual who assists in the training of staff on items including but not limited to technical aspects of the laboratory and associated analytical practices. These functions are guided by the principles of Good Clinical Practices (GCPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs) (21 CFR Parts 11, 50, 56, 58) as well as related guidance from the Organization for Economic Co-operation and Development (OECD), European Medicines Agency (EMA) and (Clinical Laboratory Improvement Amendments (CLIA) as appropriate.

Detailed responsibilities include, but are not limited to, support of these objectives:

• Staff are skilled, trained and available to support new business.
• Staff are developed and trained in an ongoing manner.
• The facility, devices and material under their control is safe, proper, secure, correctly documented, cleaned, inspected, maintained, calibrated, validated and sufficient for their assigned tasks.
• Computer systems are suitable for their intended purpose and are validated and maintained.
• Materials and records are retained, archived and maintained under conditions that ensure their integrity and continued access.

The Senior Specialist, Lab Trainer spends a majority of their time on the Laboratory floor as a mentor, technical guide and process monitor. Among the expected roles are aiding senior training staff in the following:

• Onboarding new hires with technical laboratory training with regards to ligand binding assays and other areas as appropriate.
• Re-train existing staff to improve their laboratory techniques as requested.
• Development and training of junior staff both technically and in the soft skills needed for advancement in a fast-paced CRO environment.

Essential Functions

• Real
  - Time Staff Stewardship
  • Maintain TLM-DE operational capacity by orienting, on-boarding and training new staff.
  • Organize, author and administer recurring staff training in compliance with corporate SOPs.
  • Coordinate with leadership on issues which impact laboratory services.
• Real-Time Laboratory Stewardship
  • Help to, and direct lab staff in best habits to keep the laboratories and all the devices clean, operational and presentable.
  • Interact with support teams for maintenance and qualification issues.
  • Provide input to management on future needs including formulating and executing strategies, renovations, and infrastructure for adequate manning, space, and facilities.
  • Maintain laboratory equipment performance by developing and executing operations, quality, and troubleshooting procedures.
  • Govern safety checks of laboratories, including biohazards.
  • Maintain inventory of reagents and consumables; anticipate supply needs; place and expedite orders for supplies; verify receipt of supplies.
• Communication
  • Respond to every communication, internal and external, in real-time.
  • If this is not possible, respond within a few hours, preferably before close of business (COB) for that d