Job Description
This is a remote position.
Details
Job Posting ID:
ISIJP00011727
Job Posting Title:
Technical Support Engineer 4
Description:
IMPORTANT: Suppliers should not submit workers whose physical residence is within the following states due to Intuitive tax and operating entity structure:
Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.
Please interpret this as Intuitive policy to which all suppliers are required to comply.
**********************************************************************************
***Important Notes to supplier: *** (US)
-Sub-vending not allowed - Worker needs to be on your direct W2.
- Need to do a proper-pre technical screening.
- Need to have recruiter screening summary on top of resume.
- Including Skill matrix and Writeup from worker on these skills is a plus.
- All past projects should have durations and locations
- Ensure that candidate resumes include availability, location, initial screening notes -While accepting the interview request in Fieldglass, add the candidate contact details in the comments section.
-Confirm the candidate’s availability and attendance on the interview day. If the candidate is unresponsive or unable to attend, please inform us in advance.
-All submitted profiles must be within proposed bill rate
• Actual Job Posting Title: Senior Consultant, CMC / GMP Documentation & Quality Control • Duration: 1 year • Contract/possibility for conversions: Possible based on the need and performance •• Onsite/Hybrid/Remote: Remote, Sunnyvale • Only Locals/Nonlocals can be submitted: Local/Non local both • Mode of interview: Zoom • No of rounds of interview: 3 • New JP or Backfill position: New Req
Job Description-
Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports- Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements- Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions- Support QC documentation review activities related to analytical methods, test records, and data packages- Provide QC documentation and quality review support for technology transfer activities, as needed- Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies- Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete- Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics- Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners- Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements- Collaborate closely with CMC, QA, Regulatory Affairs, and external partners
Job Posting Start Date:
03/16/2026
Job Posting End Date:
02/28/2027
Business Unit:
Corp Admin
Site:
Remote (CA)
Location:
Sunnyvale
Requirements
Requisition Number:
ISIJP00011727
Title:
Senior Consultant, CMC / GMP Documentation & Quality Control
Pay Rate:
$180.00/HR W2
(Team, please don’t offer the highest pay rate upfront. First try to understand what pay rate the candidate is expecting, and then proceed accordingly.)
Location:
Sunnyvale, CA
Note: This role requires
pharma/biotech CMC documentation experience
.
This is a
senior quality documentation consultant
role within the
pharmaceutical / biotech industry
.
Consultant in this role will
review
(technical and quality documents)
and ensure regulatory compliance
(FDA, EMA, ICH)
of manufacturing and quality documentation
related to drug products.
Must Have Skills:
Someone with 10+ years in
pharma or biotech
and strong
CMC documentation review experience.
CMC documentation experience
FDA/ICH/EMA regulatory knowledge
GMP compliance expertise
QC lab documentation review
Batch record / validation doc review
OOS/OOT investigation experience
Inspection readiness (FDA/EMA)
To better understanding of this role:
Think of this person as the quality gatekeeper for all written records in a pharmaceutical or biotech company. Before any drug product reaches the FDA or other global health agencies, mountains of paperwork must be perfect specifications, test records, manufacturing instructions, validation reports, and stability data.
QUESTION TO ASK
Can you walk me through your experience reviewing CMC documentation?
Which FDA and ICH guidelines are most relevant to your work?
Have you supported or participated in an FDA or EMA inspection?
Tell me about a time you identified a critical documentation gap. What happened?
Have you reviewed documentation from CDMOs or external labs?
Try this LinkedIn Search: (Copy & paste on google search bar)
site:linkedin.com/in ("CMC documentation" OR "GMP documentation") AND ("QC review" OR "quality control") AND ("FDA" OR "ICH guidelines") AND ("batch records" OR "validation") AND (pharmaceutical OR biotech OR biopharmaceutical) AND (California OR "Sunnyvale" OR "Bay Area" OR remote)