Administrator I, QC

Administrator I, Quality Control

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! The Administrator I, QC is a key contributor for the smooth operation of the Operations unit within QPS, Department of Translational Medicine specifically, Laboratory & Compliance Management (LCM).

Quality Control (QC) ensures that controlled documents are accurate for data, processed and signed according to federal regulations, scanned and archived according to SOP and finally, electronically organized and accessible to staff, clients and regulatory bodies around the world. The process is regulated and vital to the success of clinical trials around the world.

The successful candidate helps to assure QPS records comply with FDA regulations, GLPs and QPS Standard Operating Procedures.

This role requires comfort with computer systems and databases. Though part of a larger Management team, there are multiple daily interactions and troubleshooting with operations staff, vendors and clients. Administrator I's are trained and supported by process and technical experts.

This role requires independence, attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the successful candidate. The role is for a team member who can share responsibilities and do what is needed in the moment especially in a dynamic environment.

No visa sponsorship (e.g. H-1B, L-1, E) will be provided for this active position, now or in the future. Applicants must currently be authorized to work in the U.S. on a permanent or unrestricted basis.

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 Neuropharmacology, 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!

The Job :

Quality Control (QC) of records ensures that work assignments are completed in a safe manner and in accordance with SOPs and GLP regulations.

Identify inconsistencies in data tables and draft reports.

Manually generated raw data and transcriptions require a 100% verification.

Verify accuracy of study reports for data consistency within the report, text and tables and figures, and for data consistency between notebook and report.

Review and verify accuracy of draft reports in terms of format and style (may be client specific), text content, tables and figures.

Verify all study components expected in the study records are included to ensure a well-organized and disclosed study.

Manage the QC record requests and ensure that assignments are completed to meet client timelines.

Verify laboratory logbooks for completeness prior to archiving.

Manage and organize the laboratory logbook requests and archival information.

Review and verify accuracy of raw data and data tables for compliance with applicable client requirements, study protocol, in-house SOPs, and Good Laboratory Practices (GLPs).

Working closely with Operations, Sample and Data Management, Project Management, and QA to coordinate timelines and deliverables.

Work Location :

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

Requirements :

Bachelor's Degree plus ? 2 years relevant industry experience

Prior QC or QA experience 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.