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Company Contact Info
- Newark, DE 19711
- Alexis Delle Donne
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Senior Operations & Business Management Analyst
QPS Holdings, LLC • Newark, DE
Posted 2 months ago
QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995. Please visit our website (www.qps.com) for more information and to see all current openings.
Projects in translational medicine (TLM) include method transfer of assays originated from the sponsor's lab, validation of commercially available kits and methods or a collaborative effort between the QPS team and our client for custom assays. Our Orders & Business Management team supports the smooth operation of the unit by maintaining accurate financial and operational tracking systems that will be used to develop status reports and communications.
This senior level staff member must be familiar with the basic study elements of a bioanalytical project, and well versed in the basic culture of science in an FDA regulated environment, the programs and databases of computer systems, as well as the principles of finance and accounting.
• Identify and initiate proposal revisions: Correspond with sponsor contract manager to initiate the revision process
• Update individual project matrix file, derive updated scope cost and compare with the initial proposal.
• Generate recommended proposal revision language for the Senior Director of OBM to review.
• Finalize proposal document with client textual edits, formats, and signatory as necessary.
• Transfer proposal revision information into any other client-directed change order form that is separate from the QPS proposal
• Track revised proposal status and field status inquiries from TLM operation and supporting units.
• Database maintenance: ensure the completeness of timeline tasks in TLM project database.
• Complete project tracking tasks, to include ensuring status updates for priority projects, updating database to indicate invoiced items and new forecast activity, forward files to invoicing.
• Complete end of study tracking and reconciliation, to include confirming study closure via PI, invoice-payment closure with invoice team, sample storage status with Sample Management, and maintaining a post-study status log.
• Organization and time management skills
• Demonstrated computer skills, such as standard Microsoft Office Suite
• Experience with database structure and usage (LIMS, Access, Quick Base)
• Able to adapt to a controlled business environment in the context of GLP regulations and Quality Systems
• Strong English language and grammar skills
• Proven ability to recognize problems, identify unexpected results, and take action
Education/Experience – Degree in biomedical field preferred
• Master's Degree plus ≥ 2 years relevant industry experience or 1 year CRO experience
• Bachelor's Degree plus ≥ 2 years direct relevant industry experience
• Associate's Degree plus ≥ 7 years relevant industry experience
• Experience in proposal preparation, customer service and/or client support experience in the CRO of life science 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.