Pharma Documentation Specialist — Compliance & Processes

Merck & Co.; Hauppauge (NY); On-site; USD 28,000 - 36,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

Paid time off

Parental leave

Job summary

InvaGen Pharmaceuticals, Inc. seeks an Assistant Documentation Specialist to support packaging operations, document control, and technical writing in a pharmaceutical manufacturing setting in Central Islip or Hauppauge, NY.

The role requires 1–3 years in pharma, strong analytical and writing skills, and proficiency with Microsoft Office. 1st shift, full-time, hourly pay. CIPLA family of companies offers a comprehensive benefits package.

Qualifications

• BA/BS degree in a related field required.
• 1-3 years of pharma manufacturing experience preferred.
• Advanced analytical and mathematical skills.
• Excellent written and verbal English communication.
• Strong documentation and technical writing skills.
• Knowledge of cGMP and FDA guidelines.

Responsibilities

• Prepare and review Change Controls, Deviations, Methods, Specifications, COAs, Batch Records and validation docs.
• Support technical writing, CAPAs, change controls and validation activities.
• Apply process-improvement methods to packaging operations.
• Craft and refine technical documents and source content.
• Analyze data and provide actionable recommendations.
• Follow SOPs for document creation and storage.

Skills

Analytical skills

Communication

English fluency

Microsoft Office

Documentation writing

Process improvement

Lean / 5S

Education

BA/BS degree in related field

Tools

Microsoft Office

Job description

InvaGen Pharmaceuticals, Inc. seeks an Assistant Documentation Specialist to support packaging operations, document control, and technical writing in a pharmaceutical manufacturing setting in Central Islip or Hauppauge, NY.

The role requires 1–3 years in pharma, strong analytical and writing skills, and proficiency with Microsoft Office. 1st shift, full-time, hourly pay. CIPLA family of companies offers a comprehensive benefits package.