Administrator I, Lab Trainer

QPS, LLC • Newark, DE

1d • Onsite

About The Position

The Administrator I, Lab Trainer is an advanced 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 Administrator I, Lab Trainer is an individual who trains staff on items including but not limited to technical aspects of the laboratory and associated analytical processes. 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.

Requirements

• Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as: 
• University/College Degree in relevant Scientific discipline, and/or 
• Demonstrated experience in CRO, Clinical Research, or other relevant field. 
• Experience in a Regulated industry laboratory preferred.

Responsibilities

• 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.
• 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.
• 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 day.
• If the response requires examination or coordination with others, immediately reply as such, and set a time to provide a resolution, preferably within a business day.
• Immediately update superiors and/or internal stakeholders regarding lapses in timelines, assay performance, data, or reports and work with them to effectively address any issues that may arise.
• Assist in communicating issues to stakeholders clearly and completely and list potential solutions.

Benefits

• Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
• Structured Career Ladders that provide excellent growth based on your personal aspirations.
• Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
• Park-like setting in Newark, Delaware
• Internal committees designed with the needs and enjoyment of QPS employees in mind.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees