Job Description

Job Description

Job Description

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you!

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.

If this sounds like your ideal work environment, then we would love to speak with you, so apply today!

Please visit our website ( for more information and to see all current openings.

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 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.

Work Location

• This job will be 100% QPS-office/facility based

Requirements

Education / Experience

• 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.

Why You Should Apply

• 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.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.

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