R&D Assay Documentation & QA Submissions Specialist

Tempus AI; Illinois; On-site; USD 50,000 - 65,000; Full time

Job summary

Tempus AI is seeking a documentation specialist to support IVD regulatory submissions. You will draft, edit, and maintain GMP/ISO-compliant documents for the molecular R&D group and collaborate with scientists, technologists, and QA/regulatory professionals.

The role emphasizes meticulous record-keeping, version control, and audit preparation in a fast-paced environment. A Bachelor’s degree plus 2+ years in medical device documentation is expected.

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.

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

Documentation

Detail oriented

Written communication

Cross-functional collaboration

Team player

Education

Bachelor's degree in a related field

Job description

Tempus AI is seeking a documentation specialist to support IVD regulatory submissions. You will draft, edit, and maintain GMP/ISO-compliant documents for the molecular R&D group and collaborate with scientists, technologists, and QA/regulatory professionals.

The role emphasizes meticulous record-keeping, version control, and audit preparation in a fast-paced environment. A Bachelor’s degree plus 2+ years in medical device documentation is expected.