Quality and Documentation Specialist I

FLSA Classification: Non-exempt/Hourly 

Schedule: Monday to Friday; 8:00am to 5:00pm; On-site 

Department: Precision Medicine & Biomarkers  

Reports to: Associate Director, Precision Medicine & Biomarkers  

Supervisory responsibilities: No 

Location:  13202 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The Document Specialist will be responsible for playing a crucial role in ensuring the accuracy and compliance of documentation within a clinical laboratory environment including the CLIA/CAP lab at Immatics US Inc.    

Essential functions: 

• Document Review: Carefully review and verify the accuracy of all documentation related to laboratory processes, ensuring compliance with CLIA/CAP standards and FDA regulations. Additionally, monitor and resolve any ambiguities that may arise in the documentation. 

• Quality Control: Review quality control check documents on laboratory instruments, reagents, and assays to ensure accuracy and compliance with regulatory standards. Assign Proficiency Testing samples to CLIA personnel. 

• Instrument Maintenance: Support and track instrument maintenance and calibration, including scheduling and documentation of maintenance activities. 

• Patient Records: Manage and safeguard patient-related documentation, including test results, sample information, and other relevant records in the archival room. 

• Chain of Custody: Oversee the chain of custody documentation, ensuring the integrity and traceability of clinical samples and specimens throughout their journey within the laboratory. 

• Personnel Binders: Maintain and update personnel binders, including certifications, training records, and other relevant documents for laboratory staff. 

• Audit Preparation: Assist in the preparation for internal and external audits by ensuring that all necessary documentation is readily accessible and in compliance with regulatory standards. 

• Change control: Collaborate with relevant teams to support the implementation of change control processes, ensuring that all documentation is updated and compliant with new procedures. 

• Database and Data Tracker review: Participate in the review and maintenance of databases and data tracking systems, ensuring data integrity and accuracy. 

• Electronic Data Transfer: Ensure the secure and accurate transfer of electronic data, including data integrity checks and records of data transfer activities. 

• TMF Filing: Provide essential study- related documents following the regulatory requirements for the Trial Master File (TMF) management. 

• Assist in the planning, implementation, and monitoring of the Quality Management System to ensure compliance. 

• Conduct training sessions as required for existing employees and orientation to new onboarding employees within the Precision Medicine and Biomarkers team 

Secondary functions: 

• Attend organizational meetings. 

• Conduct quality meetings with teams as needed. 

• Attend clinical laboratory related continuing education webinars/ courses. 

•  Other duties as assigned. 

Competencies 

• Attention to Detail 

• Organization skills 

• Communication 

• Adaptability and Time Management 

• Problem Solving 

Work environment: 

This is a sedentary position (at least 50% of time) in a typical office/clinical environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens and toxic or caustic chemicals. 

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. 

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Pushing - Exerting force upon an object so that the object moves away from the object. 

• Pulling - Exerting force upon an object so that the object moves toward the force.  

• Sitting – remaining in a sitting position for at least 50% of the time. 

• Standing/Walking - remain on one's feet in an upright position at a workstation.  

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.  

Required education and experience 

• A bachelor’s degree in a relevant field or equivalent work experience. 

• Attention to detail and strong organizational skills and ability to manage multiple projects simultaneously. 

• Proficiency in document management and record-keeping (GDP). 

• Proficient in Microsoft Office programs such as Outlook, SharePoint, Planner, Excel, Word, PowerPoint, and Teams 

Preferred education and experience 

• Knowledge of CLIA and regulations and standards, 

• Experience in document control within a clinical laboratory setting 

Additional eligibility requirements: 

• B. S. in Biology or related scientific discipline. 

• 0-2 years of relevant academic/industry experience. 

Work authorization/security clearance requirements 

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment 

Affirmative Action/EEO statement 

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical​​​ conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.” 

Other duties