Documentation Specialist - Dpi

Cipla Ltd

Central Islip, New York, United States
Base: $66,300-$86,000; bonus/equity: eligible for ...
On-site
Gmp batch record creation and revision
Sop development and periodic review
Experience with deviations and capas
The Documentation Specialist is responsible for creating and revising GMP batch production records and SOPs while ensuring accuracy and integrity

Job Summary

  • The Documentation Specialist is responsible for creating and revising GMP batch production records and SOPs while ensuring accuracy and integrity.
  • Candidates will manage quality records including change controls, CAPAs, and deviations, delivering them to established timelines.
  • The company offers a comprehensive benefits package including health insurance, 401(k) matching, and paid time off.

Matching Summary

The Documentation Specialist is responsible for creating and revising GMP batch production records and SOPs while ensuring accuracy and integrity.

Salary

Base: $66,300-$86,000; Bonus/Equity: Eligible for performance-based bonus program; Benefits: Comprehensive package including 401(k), health/dental/vision, HSA/FSA, PTO, and parental leave

Skills & Requirements

Must-have

  • GMP batch record creation and revision
  • SOP development and periodic review
  • Experience with deviations and CAPAs
  • Knowledge of cGMP and GDP practices
  • Proficiency in Microsoft Office Suite

Nice-to-have

  • Experience with electronic document systems
  • Background in generic pharmaceutical manufacturing
  • Dry product (DPI) manufacturing experience
  • Statistical analysis tools proficiency
  • Root cause investigation leadership

Key Requirements

  • Associate degree required
  • Bachelor's or Master's degree preferred in science or pharmaceutical engineering
  • Minimum 1 year documentation experience
  • Minimum 3 years pharmaceutical or biotech industry experience
  • Local applicants only for US subsidiaries

Work Rights

Not specified

Tailored Resume

Cover Letter