Laboratory Documentation Specialist

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a critical contributor to laboratory operations in the generation and update of design documents, SOPs, checklists, and other documentation for the management and performance of diagnostic assays. The position involves applying experience in quality and regulatory documentation to support the molecular LabOps group (in collaboration with R&D) in drafting documentation for regulatory submissions. You will work closely with laboratory management, technologists, as well as Quality and Regulatory professionals.

What you’ll do:

• Draft and edit quality system-compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
• Drive change control processes with affected stakeholders.
• Support maintenance of appropriate regulatory filings
• Documentation review for consistency and compliance
• Help oversee the implementation of new documentation and version control
• Serve as a point of contact for documentation retrieval
• Aid in preparation for internal and external audits 
• Manage multiple sources of information for documentation purposes
• Help to improve IVD and LDT development documentation and processes continuously
• Track document changes for high-priority initiatives, and follow up with Stakeholders to ensure the timely completion of reviews, edits, and approvals
• Other duties as assigned

Qualifications:

• Bachelor’s degree plus 2 years of documentation experience in the medical device industry
• Organized and detail-oriented
• Excellent written and verbal skills
• Ability to work well will cross-functional teams 

Highly desirable:

• Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques
• Ability to thrive in a fast-paced environment
• Detail-oriented and highly organized
• Familiarity with a range of QMS systems and regulatory submissions
• Familiarity with CLIA, CAP, ISO13485, and FDA QSR

 

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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.