Assistant Documentation Specialist

Location: Central Islip or Hauppauge, NY

Employment Type: Hourly - Full Time

About the Role

Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in key markets, including the U.S. through our subsidiary, InvaGen Pharmaceuticals.

Responsibilities

• Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports.
• Conduct focused time-studies to support packaging operations.
• Support technical writing and Packaging investigations, Corrective Action Preventive Actions (CAPAs), change controls, and validation activities as required.
• Apply complete knowledge of process improvement strategies and lean techniques (e.g., Method analysis, work combination charts, ergonomics, visual controls, safety, 5S, Fishbone Diagram, Kanban, poka yoke) to analyze and improve overall packaging operations.
• Participate in crafting and refining ideas, cultivating sources, and developing technical documents.
• Perform and direct data mining and analyze results to provide recommendations or conclusions.
• Review and edit content for compliance, clarity, and proper use of terminology with strict attention to detail.
• Follow documented SOPs for creating and storing documents.
• Work independently and collaboratively with strong analytical skills to collect, organize, and analyze data for recommendations and performance monitoring.
• Perform administrative functions as directed by Management to support projects and ensure smooth department operation.
• Actively participate in Root Cause Analysis to identify areas for improvement, including process redesign, workflow alignments, and elimination of redundant tasks to create safe, standard, and effective action plans.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to Cipla’s Safety, Health, and Environmental policies.
• Exercise appropriate professional judgment on matters of significance.
• Work in a pharmaceutical manufacturing setting.
• Perform other duties as assigned by Manufacturing Management.

Requirements

• BA/BS degree in a related field of study from an accredited college/university.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing; preference given to candidates with experience in generic pharmaceutical manufacturing.

Skills

• Advanced analytical and mathematical skills.
• Ability to communicate the needs and agenda of the packaging department to other groups.
• Excellent written and verbal communication skills; fluent in English.
• Strong knowledge of Microsoft Office applications (Word, Excel, PowerPoint) and PDF tools for creating, editing, drafting, and controlling documents.
• Good understanding of cGMP, current technologies, and FDA guidelines.
• Able to prioritize, plan, and work under tight schedules and deadlines.
• Strong documentation and technical writing skills with the ability to apply relevant scientific principles and practices.
• Clear and concise communication across all levels, both orally and in writing.

Benefits

• 401(k) savings plan with company matching.
• Comprehensive health insurance (medical, dental, vision).
• Health Savings Account (HSA) and Flexible Spending Account (FSA).
• Paid time off (PTO) including vacation, sick leave, and flex time.
• Paid holidays.
• Short-term and long-term disability (STD, LTD).
• Parental leave and paid/unpaid family leave.
• Employee discounts and other benefits.

Pay

Hourly range: $20.00 - $26.00. Exact salary depends on experience, skills, education, and budget. Salary may vary based on geographic location.

Schedule

1st shift: 7:00 AM - 3:30 PM