Quality Control (QC) Validation Scientist 100% remtote

Job Title: Quality Control (QC) Validation Scientist

Remote

Job Summary

Takeda is seeking a Quality Control (QC) Validation Scientist to support Analytical Quality Control (AQC) and Microbiology (QCM) activities in a cGMP-regulated environment. The ideal candidate will be responsible for analytical method validation, transfer, troubleshooting, and compliance, ensuring all laboratory operations meet regulatory and quality standards.

Candidates with a Microbiology degree or relevant experience will be prioritized for immediate interviews.

Mandatory Submission Requirements (Profiles without these will be rejected):

• Photo ID
• Month & Day of Birth
• 2–3 Professional References (Must include):
  • Company email IDs
  • Manager contact numbers
  • LinkedIn profiles

Key Responsibilities

• Drive analytical method validation and transfer of laboratory methodologies
• Execute and support test plans, protocols, and discrepancy resolution
• Troubleshoot analytical methods and recommend improvements
• Ensure laboratory equipment remains in a validated and compliant state
• Author and review protocols, reports, and technical documentation
• Support raw material qualification for new products
• Apply scientific principles and statistical analysis to solve complex problems
• Assist with installation, operational qualification (IOQ), and maintenance of QC instrumentation
• Ensure all deliverables meet timelines, milestones, and regulatory expectations

Required Qualifications

• Bachelor’s Degree in:
  • Microbiology (Highly Preferred)
  • Biotechnology
  • Chemistry
  • Pharmacy or related field
• Minimum 1+ year of experience in:
  • Analytical method validation or development
  • Pharmaceutical / Biopharmaceutical / cGMP environment

Required Skills & Expertise

• Strong knowledge of:
  • Analytical method validation
  • cGMP regulations and lab compliance
  • Regulatory standards: USP, 21 CFR, ICH, QSR
• Experience with data analysis and statistical techniques
• Strong technical writing and documentation skills
• Ability to troubleshoot and resolve complex lab issues
• Proficiency in Microsoft Office tools
• Strong organizational, multitasking, and time management skills

Preferred / Nice-to-Have Skills

• Experience with KNEAT validation software
• Familiarity with:
  • Equipment qualification (IQ/OQ/PQ)
  • Computer System Validation (CSV) – SCADA, MES
  • QC/Microbiology lab instrumentation validation
• Experience in paperless validation systems

Work Environment

• Onsite laboratory and office setting
• May work in cleanroom environments with gowning requirements
• Exposure to chemicals (alcohols, acids, buffers)
• May require extended work hours based on project needs

Additional Notes

• Strong preference for candidates with Microbiology background
• Candidates must be comfortable working in a regulated pharmaceutical environment
• Immediate interview consideration for highly relevant profiles