What are the responsibilities and job description for the Test Method Validation Consultant position at i-Pharm GxP?
Job Title: Senior Test Method Validation Consultant - TOC / Analytical Methods
Location: Bedford, Massachusetts
Contract: Initial 6-Month Contract (Likely Extension)
Overview
This role is heavily focused on analytical test method development, execution, troubleshooting, and validation activities surrounding TOC (Total Organic Carbon) analytical methods and associated laboratory systems. The successful consultant will play a key role in developing, optimizing, validating, and improving analytical methods used within the QC laboratory environment.
The immediate focus will involve Shimadzu TOC analytical systems used to support cleaning verification testing, with broader laboratory method improvement activities expected longer term.
Key Responsibilities
- Lead hands-on Test Method Validation (TMV) and analytical method development activities within the laboratory.
- Develop, optimize, troubleshoot, and validate TOC analytical methods using Shimadzu TOC systems or similar instrumentation.
- Execute validation protocols, robustness studies, verification activities, and analytical method lifecycle support.
- Support method troubleshooting, parameter optimization, and analytical performance improvements within the QC lab.
- Generate and review validation documentation including protocols, reports, SOPs, and supporting GMP documentation.
- Collaborate cross-functionally with QA, QC, manufacturing, and analytical laboratory teams.
- Support broader analytical method improvement and validation initiatives across the laboratory environment.
Required Experience
- Strong hands-on Test Method Validation (TMV) and analytical method development experience within GMP-regulated laboratories.
- Direct experience working with TOC analytical methods and TOC instrumentation.
- Experience with Shimadzu TOC analyzers highly preferred.
- Strong analytical instrumentation background including HPLC, UPLC, GC, LC-MS, or comparable analytical systems.
- Experience executing analytical methods within pharmaceutical, biotech, medical device, or regulated manufacturing environments.
- Practical troubleshooting experience related to analytical methods and laboratory instrumentation.
- Strong understanding of GMP documentation and validation lifecycle activities.
Preferred Background
- Experience supporting analytical methods tied to cleaning verification or cleaning-related testing.
- Experience operating within sterile or aseptic manufacturing support laboratories.
- Previous consulting or contractor experience within GMP laboratory environments.
- Comfortable operating independently within a fast-paced onsite analytical laboratory setting.