Temp, Senior Quality Control Specialist

Labconnect International Ltd•Johnson City, TN

39d•Remote

About The Position

The Temp, Senior QC Specialist position collaborates with staff and leadership for reviewing documents from expedited medium or high complexity study setup or amendment to ensure accuracy and completeness of information. They will review Operational Specification Documents (OSD) to ensure client expectations are met and liaise with other departments to ensure processes are correct and efficient for each department as well as to service client needs. They will help with managing Quality Events as they relate to Quality Control. Other duties may be required and assigned.  This is a fully remote role.

Requirements

Associate s degree (A.A.A., A.S, A.A.S), or 4 years customer clinical research industry experience, 4 years set-up-related experience and/or Clinical Trials Materials or clinical specimen collection kit build experience.
Excellent organization, communication, multitasking skills.
High attention to detail.
Excellent attention to detail, strong planning, and problem-solving skills.
Excellent organizational and time management skills.
Excellent listening and verbal comprehension skills.
Must be able to multitask throughout the workday, driving completion of work towards deadlines.
Ability to make well-thought-out decisions and adapt to changing environments and requirements.
Self-motivation and ability to work well independently as well as using a collaborative team approach.
Ability to adhere to established timelines, processes, and procedures.
Proficient in Microsoft Word, Excel, and database software.
Ability to comprehend project specific budgets.

Nice To Haves

Bachelor's degree (B.A./B.S.) preferred;
Experience in contract research and/or research setting preferred.
Clinical Research, Central Lab, and/or Project Management experience outside of LabConnect will be considered.

Responsibilities

Participate in the Quality Event process for Quality Control, including Quality Event entry, tracking, performing root cause analysis, and establishing corrective and preventative action.
Responsible for participating as a Subject Matter Expert on behalf of Quality Control and verifying the effectiveness of any proposed corrective and preventative action measures.
QC of laboratory specification documents for accuracy of data or information presented including Operational Specification Document (OSD), Testing Schedules, Blood Volume Charts, Exclusion/Alerts/Blinding programing, Kit components (kit builds, requisitions and labels), and Laboratory Manuals.
Verify documents completeness and consistency within a document and between related documents, including but not limited to study protocols, budgets, kit components, requisitions, and labels. and internal scope of work documents.
Work closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment, and PRM teams to resolve problems or quality findings identified during QC review.
Partner with PRI, Project Amendment and PRM to ensure milestones are met.
Capture detailed documentation of noted QC finding for each document reviewed.
Capture, maintain, and analyze findings for trend analysis, metrics, and opportunities for enhanced training and process improvements.
Work performed must be in accordance with ICH Guidelines for Good Clinical Practice.
Assure that all QC findings and deviations are shared clearly and in timely with the applicable study manager or team to be corrected or addressed in a manner consistent with good practices and company SOPs.
Effectively and respectfully communicate with lab personnel or Project Managers to resolve any discrepancies or address any open questions or concerns.
Performs other related duties and tasks as necessary or as assigned.