R&D Assay Documentation Specialist (HYBRID: Chicago, IL)

Tempus; Chicago (IL); On-site; USD 50,000 - 55,000; Full time

Benefits offered by this job

Benefits package

Stock options

Incentive compensation

Job summary

Tempus is seeking a documentation specialist for IVD projects to generate design documents, reports and SOPs supporting regulatory submissions. You will collaborate with Technical and Development Scientists, as well as Quality and Regulatory professionals, applying your experience in quality documentation in a medical device context.

The role requires on-site presence three days a week at our Chicago office and involves preparing validated documentation, maintaining filing systems, and

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 with cross functional teams
• Team driven
• Experience in a lab setting in life sciences and understanding of molecular biology and associated techniques
• Familiarity with a range of QMS systems and regulatory submissions
• Familiarity with ISO 13485 and FDA QSMR #LI-DA1

Responsibilities

• Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
• Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
• Track batch records and checklists produced during IVD clinical validations and ensure compliance
• Maintain appropriate filing systems
• Documentation review for consistency and compliance
• Help oversee 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 continuously improve IVD and LDT development documentation and processes

Skills

Organization

Written/verbal communication

Cross-functional teamwork

Team oriented

Lab experience (life sciences)

Fast-paced environment

QMS familiarity

Regulatory submissions

Education

Bachelor’s degree

Job description

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 key contributor for IVD projects in the generation of design documents, reports, SOPs, and other documentation towards the development of diagnostic assays. The position involves applying experience in quality and regulatory documentation to support the molecular R&D group in drafting documentation for regulatory submissions. You will work closely with Technical and Development Scientists, technologists, as well as Quality and Regulatory professionals.

*This role requires the selected candidate to be on site 3 days a week at our Chicago office*

What you’ll do:

• Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
• Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
• Track batch records and checklists produced during IVD clinical validations and ensure compliance
• Maintain appropriate filing systems
• Documentation review for consistency and compliance
• Help oversee 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 continuously improve IVD and LDT development documentation and processes

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
• Team driven
• 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
• Familiarity with a range of QMS systems and regulatory submissions
• Familiarity with ISO 13485 and FDA QSMR #LI-DA1
• CHI: $50,000-$55,000
• The expected salary range may vary for other locations.
• Actual salary may vary based on qualifications and experience.

Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

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.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. We’re looking for people who can change the world. Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.