<div> <div><span style="font-family: Verdana; font-size: 16px;"><span style="color: #000000;"><strong>Overview</strong></span><br><br>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.<br><br>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.<strong> </strong></span></div> </div><p> </p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Job Summary</span></strong></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 12pt; font-family: verdana, geneva; color: black;">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.</span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 12pt; font-family: verdana, geneva; color: black;">This is a remote role.  </span></p> <p style="margin: 0in 0.1in 0in 0in; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"> </p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Essential Duties and Responsibilities</span></strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;"> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">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.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">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. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Verify documents are completed on most recent template versions. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Cross departmental collaboration to ensure QC reviews are consistent with current process and quality standards. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Work closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment and PRM teams to resolve problems or quality findings identified during QC review.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Oversee and facilitate QC timelines with PRI, Project Amendment and PRM to ensure milestones are met. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Capture detailed documentation of noted QC finding for each document reviewed.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Capture, maintain, and analyze findings for trend analysis, metrics, and opportunities for enhanced training and process improvements. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Work performed must be in accordance with ICH Guidelines for Good Clinical Practice. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">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.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">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.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">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.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Work as a liaison between support groups as applicable. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">As needed, interfaces with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem solving.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Effectively and respectfully communicate with Project Managers to resolve any discrepancies or address any open questions or concerns.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Provide back-up assistance for other departmental functions, when needed.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Train incoming employees in all departmental processes.</span></li> <li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Performs other related duties and tasks as necessary or as assigned.</span></li> </ul> <p style="margin: 0in; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"> </p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Education and Experience</span></strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;"> <li style="margin: 0in 0in 0in 0px; line-height: normal; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva; color: black;">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. </span></li> <li style="margin: 0in 0in 0in 0px; line-height: normal; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva; color: black;">Experience in contract research and/or research setting preferred.  </span></li> </ul> <p style="margin: 0in; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"> </p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Skills and Ability</span></strong></span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Excellent attention to detail, strong planning, and problem-solving skills. </span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Excellent organizational and time management skills.</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Excellent listening and verbal comprehension skills.</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Must be able to multitask throughout the workday, driving completion of work towards deadlines.</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Ability to make well-thought-out decisions and adapt to changing environments and requirements.</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Self-motivation and ability to work well independently as well as using a collaborative team approach.</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Ability to adhere to established timelines, processes, and procedures.</span></li> </ul> <ul style="margin-bottom: 0in; margin-top: 0px;"> <li style="margin: 0in 0in 0in 0px; line-height: normal; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; font-family: verdana, geneva;">Proficient in Microsoft Word, Excel, and database software</span></li> </ul> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;"> </span></strong></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Supervisory Responsibilities:</span></strong><span style="line-height: 115%;"> <strong> </strong> None</span></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Physical Demands: </span></strong></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">While performing the duties of this job, the occupant is regularly required to:</span></p> <ul style="margin-bottom: 0in; margin-top: 0px;"> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Prolonged periods of sitting at a desk and working on a computer.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Prolonged use of computer and headphones for conference calls.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Communicate effectively via phone, video, and email.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.  </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Use hands and fingers to operate a computer and other office equipment.</span></li> </ul> <ul style="margin-bottom: 0in; margin-top: 0px;"> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Walk and/or reach with hands and arms.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Read text of various sizes.</span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.  </span></li> <li style="margin: 0in 0in 0in 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Communicate with others and hear.</span></li> <li style="margin: 0in 0in 8pt 0px; line-height: 115%; font-size: 12pt; font-family: verdana, geneva;"><span style="font-size: 12pt; line-height: 115%; font-family: verdana, geneva;">Lift, pull and/or push up to 25 pounds.</span></li> </ul> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong><span style="line-height: 115%;">Travel Requirements:</span></strong><span style="line-height: 115%;"> <strong> </strong> Minimal</span></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">Join our team and discover how your work can <strong>impact patients' lives</strong> around the world! </span></p> <p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><strong>Some of the Perks our LabConnectors Love:</strong></span></p> <ul> <li style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility) </span></li> <li style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">Health Benefits beginning on date of hire</span></li> <li style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community </span></li> <li style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">Short and Long-Term Disability, Life Insurance, and AD&D </span></li> <li style="font-family: verdana, geneva; font-size: 12pt; color: #000000;"><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">We celebrate our differences, which enriches our culture! </span></li> </ul> <p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">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 <strong>People First, Quality Focused, Customer Centered, Technology Driven, </strong>and <strong>Accountability Always</strong>.</span></p> <p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">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: <a rel="noopener" href="https://www.dol.gov/agencies/whd/posters" target="_blank">https://www.dol.gov/agencies/whd/posters</a></span></p> <p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">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 <a rel="noopener" href="https://www.labconnect.com/" target="_blank">https://www.labconnect.com/</a></span></p> <p><span style="font-family: verdana, geneva; font-size: 12pt; color: #000000;">If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email <a rel="noopener" href="mailto:talent@labconnect.com" target="_blank">talent@labconnect.com</a> or call +1 (423) 722-3155. </span></p>