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Biology Job in Newark, Delaware : DE 19711

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Specialist, Sample Management

QPS, LLC.Logo
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QPS, LLC.
Biotech
1 Innovation Way
Newark
Delaware
19711
click here to apply

Specialist, Sample Management Job Description

QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) since 1995 providing high quality bioanalytical LC/MS/MS contract services to clients around the world from its headquarters in the US. In 2002, QPS simultaneously launched four additional services - immunoanalytical for protein drug concentration determination; protein biomarkers/biochemical markers determination; ADME (Adsorption, Distribution, Metabolism, and Excretion); and Autoradiography. QPS, LLC has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, ADME, WBA, protein/genomic biomarker services.

The Specialist is the key contributor for the smooth operation of the Sample Management unit within QPS, Department of Translational Medicine.

Sample Management ensures that client samples and other controlled materials are received, stored, distributed, tracked and returned safely, securely, confidentially and without loss or damage. The process is regulated and vital to the success of clinical trials around the world.

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

 

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

Essential Functions

 

§ Monitor Controlled Material Laboratory equipment performance to avert loss of sample integrity, cross-contamination and staff contamination

§ Learn and run QPS specific, Watson-LIMS-based, regulatory compliant, real-time, GBA harmonized sample tracking database and supporting processes with attention to:

§ Understand an abide by IBR and HIIPA compliant privacy measures

§ Assist in the reconciliation of shipped samples with an electronic database issued by the Sponsor, the shipping manifest provided by the clinical site and the barcode and other information resident on the sample itself with the trial specific sample templates

§ Distribute on-test samples to QPS in a timely fashion

§ Recover and secure storage of off-test material in a timely fashion

§ Return off-test articles to clients or archive articles in the freezer and report the archived state for invoicing

§ Maintain daily laboratory regulatory compliance with quality; some direct action

§ Continually check for laboratory safety and security, including biohazards

§ Coordinate with and influence research staff on quality issues with impact laboratory services

§ Interact with and execute tasks on behalf of the ADMINISTATOR for corporate Quality Assurance, IT and Facilities

 


Newark Biology Job

Specialist, Sample Management Job Requirements

Competencies (“soft skills", traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)

 

  • Analytical thinking

  • Initiative

  • Thoroughness

  • Concern for standards

Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)

 

§ Organized and detailed

§ Advanced standard computer skills, especially Excel

§ Experience with database structure, management and security (LIMS, Access, Quick Base)

§ Comfortable with FDA data control systems including 21CFR11

§ Able to adapt to a controlled laboratory environment with GLP regulations and Quality Systems

§ Good interpersonal skills; comfortable interacting on a daily basis with supervisors, peers and juniors

§ A background or education in molecular biology, is considered added value

 

Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)

 

§ High School Diploma, with 2-4 years related work experience

§ Bachelor’s or Associates degree in science or technology

§ Exposure to FDA Regulated industry preferred

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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