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Technical Writer GxP & Validation Documentation

inSync Staffing

Indianapolis, IN

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JOB DETAILS
SKILLS
Application Programming Interface (API), Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Cross-Functional, Customer Relations, Detail Oriented, Document Management, Documentation, GxP, Health Insurance, Information Technology & Information Systems, Medical Equipment, Multitasking, Pharmacovigilance, Presentation/Verbal Skills, Process Validation, Project/Program Management, Source Code/Configuration Management (SCM), Standard Operating Procedures (SOP), Systems Administration/Management, Technical Recruiting, Technical Writing, Time Management, Traceability, Validation Documentation, Writing Skills
LOCATION
Indianapolis, IN
POSTED
9 days ago

JOB TITLE:    Technical Writer-Gxp & Validation Documentation
LOCATION:    Onsite Indianapolis, IN
INDUSTRY:     Pharmaceutical
 
JOB SUMMARY:   Theoris is looking for someone who will author and maintain validation-ready documentation while working closely with engineers, product managers, and subject matter experts to translate complex technical systems into clear, auditable content.


RESPONSIBILITIES:
  • Author and maintain SOPs, IQ/OQ/PQ protocols and reports, and Requirements Traceability Matrices (RTMs) within QualityDocs
  • Translate complex system configurations, API behaviors, Veeva Vault Safety workflows, and integration logic into GxP-compliant documentation
  • Partner with engineers and SMEs to extract technical knowledge and produce structured, compliance-ready content
  • Manage document lifecycle activities including version control, review cycles, and change-controlled updates
  • Support cross-functional collaboration across technical and compliance teams

 
REQUIREMENTS:
  • 3+ years of technical writing experience in a GxP-regulated pharmaceutical, biotech, or medical device environment
  • Proven experience authoring IQ/OQ/PQ protocols, SOPs, and RTMs in an EDMS such as QualityDocs
  • Working knowledge of CSV/CSA principles and applicable regulations (21 CFR Part 11, EU Annex 11, GAMP 5)
  • Conceptual understanding of REST/GraphQL APIs, authentication flows, and CI/CD pipelines sufficient to document them accurately — coding not required
  • Familiarity with Veeva Vault Safety or similar pharmacovigilance systems preferred
SKILLS & COMPETENCIES
  • Strong written and verbal communication skills
  • Exceptional attention to detail and commitment to accuracy
  • Self-directed with the ability to manage multiple projects and deadlines
  • Comfortable working across both technical and compliance-focused teams
  • Willingness to learn new technologies quickly
 
 
 
 
Best-In-Class-Benefits:  We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:
  • Robust Health Insurance
  • 401(k) plan
  • PTO
  • Paid holidays
 
About Theoris: Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.
 



 

About the Company

i

inSync Staffing

We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible. inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced. The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.
COMPANY SIZE
50 to 99 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2014
WEBSITE
http://www.insyncstaffing.com/default.html

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