Assistant Documentation Specialist

Cipla • Hauppauge, NY

3d • Onsite

About The Position

The Assistant Documentation Specialist will be responsible for preparing and reviewing various technical documents, conducting time-studies, and supporting technical writing activities within the packaging department. This role requires a strong understanding of process improvement strategies, lean techniques, and pharmaceutical manufacturing regulations. The specialist will also perform data analysis, ensure compliance with SOPs, and contribute to root cause analysis for process improvements. The position operates under general supervision and requires the ability to work both independently and collaboratively in a pharmaceutical manufacturing setting.

Requirements

• BA/BS degree in a related field of study from an accredited college/university required.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.
• Advanced Analytical Mathematical Skills.
• Ability to communicate the needs and agenda of the packaging department to other groups.
• Excellent communications and presentation skills – written and verbal; fluent in English.
• Strong knowledge in all Microsoft office computer applications (i.e., Word, Excel, PowerPoint, etc.) and pdf to create, edit, draft and control.
• Good understanding in cGMP, current technologies, and current FDA guidelines.
• Able to prioritize, plan and work under tight schedules and deadlines.
• Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
• Must communicate clearly and concisely across levels, both orally and in written.
• Strong command over written and verbal English is required.

Nice To Haves

• Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

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 the 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.
• Participates in the process of crafting and refining ideas, cultivating sources, and developing technical documents.
• Perform and direct data mining and analyze the results to provide recommendations or conclusions.
• Strict attention to detail and ability to review and edit content for compliance, clarity, and proper use of terminology.
• Able to follow documented SOPs for creating documents and storing them.
• Ability to work independently and collaboratively.
• Strong analytical skills with the ability to collect, organize and analyze data so that you may make recommendations and monitor performance.
• Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
• Actively participate in Root Cause Analysis to identify areas for improvement including process redesign, workflow alignments and adjustments, and elimination of redundant and unnecessary 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.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Must be willing to work in a pharmaceutical manufacturing setting.
• Other duties assigned as required by Manufacturing Management.

Benefits

• 401(k) savings plan and matching
• health insurance –medical/dental/vision
• health savings account (HSA)
• flexible spending account (FSA)
• paid time off (PTO) – vacation/sick/flex time
• paid holidays
• short-term disability (STD)
• long-term disability (LTD)
• parental leave
• paid and unpaid family leave
• employee discounts
• other benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level