Quality Control Specialist

Overview

Quality Control Specialist Jobs in Johnson City, TN at LabConnect

Title: Quality Control Specialist

Company: LabConnect

Location: Johnson City, TN

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

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

Join our team and discover how your work can impact patients' lives around the world!

Some of the Perks our LabConnectors Love:

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/

If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected] or call +1 (423) 722-3155.