Quality Control Specialist

Job Summary The QC Specialist is responsible for the review of low complexity study setup and study setup amendment documents to ensure accuracy and completeness of information. They will review Operational Specification Documents (OSD) and any ancillary study documents and liaise with other departments as needed to ensure that the study is set up correctly. The following responsibilities are routine for this position; however, they are not to be construed as exclusive or all-inclusive. Additional responsibilities will be assigned as needed. This is a remote role. Essential Duties and Responsibilities 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. Verify documents are completed on most recent template versions. Cross departmental collaboration to ensure QC reviews are consistent with current process and quality standards. Work closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment and PRM teams to resolve problems or quality findings identified during QC review. Oversee and facilitate QC timelines 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. Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents. Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents. Utilize eQMS to log, monitor, trend, and report quality-related actions, Quality Events, client complaints, audit findings, and CAPAs to ensure timely closure and visibility. Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations. Work as a liaison between support groups as applicable. As needed, interfaces with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem solving. Effectively and respectfully communicate with Project Managers to resolve any discrepancies or address any open questions or concerns. Provide back-up assistance for other departmental functions, when needed. Train incoming employees in all departmental processes. Performs other related duties and tasks as necessary or as assigned. Education and Experience Required - 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. Experience in contract research and/or research setting preferred. Skills and Ability 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

Supervisory Responsibilities:

None

Physical Demands:

While performing the duties of this job, the occupant is regularly required to: Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus. Use hands and fingers to operate a computer and other office equipment. Walk and/or reach with hands and arms. Read text of various sizes. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus. Communicate with others and hear. Lift, pull and/or push up to 25 pounds.

Travel Requirements:

Minimal