IVD Documentation Scientist, Manufacturing and Medical Device (Contract)
Job Location:
Palo Alto, CA - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
We are seeking an experienced scientist who is a subject-matter expert in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be the key individual responsible for the manufacturing documentation required for a high risk IVD device meeting the rigor of FDAs PMA and IVDRs Class C/D submission including Specifications and Procedures for Manufacturing Packaging Storage Handling Distribution and Process Controls. The focus will be working closely with the assay development reagent manufacturing regulatory and quality teams to craft the procedures templates and documentation that govern high-quality reagent manufacturing execution including batch records CoAs study plans reports SOPs and design history file content.
Author and revise existing reagent manufacturing and qualification procedures to ensure processes are repeatable and meet GMP and IVD quality documentation expectations including 21 CFR 820 and ISO 13485 requirements
Author batch record templates and finalize batch manufacturing records (BMRs) for GMP reagent manufacturing processes including incoming receipt in-process and release steps
Develop Certificates of Analysis (CoAs) and specification documents for GMP-grade reagents controls and raw materials aligned with regulatory expectations
Write and maintain manufacturing study plans and summary reports for lot qualification lot-to-lot variability stability and process characterization studies
Draft and revise SOPs work instructions and manufacturing process descriptions for inclusion in the Device History Record (DHR) and Device Master Record (DMR)
Develop and maintain Design History File (DHF) documentation packages to support PMA submission including manufacturing development reports risk assessments and design transfer documentation process validation equipment and software qualification
Compile and organize manufacturing evidence packages (batch records qualification data CoAs validation reports) for regulatory submission
Support other IVD documentation as needed such as FMEA BOMs trace matrix
Review CMO-generated documentation (batch records CoAs deviation reports) for GMP compliance prior to lot release
Support incoming QC workflows and receiving-to-release documentation for in-house and CMO-manufactured reagents
- Prior hands-on experience in the preparation of GMP-grade reagents controls and reference standards (formulation aliquoting labeling packaging) following SOPs and batch records
Ability to complete hands-on training and bench execution of step-by-step manual reagent preparation observe and identify potential failure modes recommend improvements and update existing documentation to meet GMP/FDA/IVD expectations
Work with reagent manufacturing operators to ensure QC testing and real-time batch records are completed during manufacturing runs
BS7 MS5 or PhD3 years in GMP manufacturing or tech transfer within IVD medical device or pharma
Hands-on experience with manual GMP manufacturing: reagent formulation controlled preparation aliquoting labeling and release QC testing
Prior experience operating lab equipment in GMP-controlled environments with strict contamination control and cleanroom protocols
Demonstrated expertise authoring GMP documentation: BMRs CoAs study plans manufacturing reports SOPs and process validation packages
Direct experience in eQMS document control including creating revising and approving quality documents.
Direct experience contributing to FDA PMA 510(k) or BLA/NDA submission packages specifically manufacturing sections
Strong working knowledge of 21 CFR Part 820 ISO 13485 and design control requirements
Experience with CMO oversight including review of CMO-generated documentation
Background in NGS-based assays molecular diagnostics or immunoassay platforms
Hands-on experience with protein- or nucleic acid-based reagent manufacturing including recombinant protein controls or reference standards
Familiarity with DHF/DMR structure CLSI guidelines ISO 14971 risk documentation and ERP/lot-tracking systems (e.g. NetSuite)
Required Experience:
IC
