Packaging Documentation Specialist - Lean & Compliance

Cipla; Hauppauge (NY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) matching

Health insurance (medical/dental/visio

Paid time off

Job summary

Cipla is seeking a Packaging Analyst to support and improve pharmaceutical packaging operations at our Hauppauge, NY site. You will prepare and review change controls, deviations, methods, specifications, COAs, batch records, and validation protocols/reports, ensuring accuracy and compliance.

Your role includes supporting investigations, CAPAs, and validation activities, applying lean methods to enhance workflows, and performing data mining to inform recommendations.

Qualifications

• BA/BS degree in a related field from an accredited college/university.
• 1–3 years of direct work experience in pharmaceutical manufacturing; preference for generic manufacturing.
• Advanced analytical mathematical skills.
• Strong documentation and technical writing abilities; fluent in English.

Responsibilities

• Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, and validation protocols/reports.
• Support packaging investigations, CAPAs, change controls, and validation activities.
• Apply lean techniques to analyze and improve packaging operations.
• Perform data mining and provide recommendations based on analyses.
• Follow SOPs and safety regulations to ensure compliant packaging operations.

Skills

Analytical skills

Communication

MS Office

Technical writing

cGMP knowledge

Cross-functional communication

Education

BA/BS degree

Tools

Microsoft Office

Job description

Cipla is seeking a Packaging Analyst to support and improve pharmaceutical packaging operations at our Hauppauge, NY site. You will prepare and review change controls, deviations, methods, specifications, COAs, batch records, and validation protocols/reports, ensuring accuracy and compliance.

Your role includes supporting investigations, CAPAs, and validation activities, applying lean methods to enhance workflows, and performing data mining to inform recommendations.