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

Ambry Genetics Corporation; Chicago (IL); On-site; USD 50,000 - 55,000; Full time

Benefits offered by this job

On-site 3 days/week in Chicago

Competitive benefits

Opportunities for growth

Job summary

Tempus in Chicago is seeking a documentation specialist to support IVD project documentation and regulatory submissions. You will draft SOPs, batch records, and work instructions, while maintaining compliant filing systems and ensuring audit readiness.

Collaboration with R&D scientists, technologists, and Quality/Regulatory teams is essential. The role requires a Bachelor’s degree with 2+ years in medical device documentation.

Qualifications

• Bachelor’s degree plus 2+ years of documentation experience in the medical device industry.
• Must be organized and detail oriented.
• Excellent written and verbal skills.
• Ability to work well with cross functional teams.
• Team driven and collaborative work style.

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

Organized

Detail oriented

Written and verbal skills

Cross functional collaboration

Team driven

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

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.