Packaging Technical Writer jobs in United States
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Cipla USA · 2 weeks ago

Packaging Technical Writer

Cipla USA is seeking a Packaging Technical Writer to join their team in Central Islip, NY. The role involves preparing and reviewing technical documents, supporting packaging investigations, and applying process improvement strategies to enhance packaging operations.

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 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

Qualification

CGMP knowledgeAnalytical skillsTechnical writingMicrosoft OfficeFDA guidelinesCommunication skillsTeam collaborationAttention to detail

Required

BA/BS degree in a related field of study from an accredited college/university required
Minimum One (1) to three (3) years of related technical writing experience
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 cGMPs, 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

Preferred

Preference will be given to candidates with experience in pharmaceutical manufacturing

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

Company

Cipla USA

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Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.

Funding

Current Stage
Late Stage

Leadership Team

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Arunesh Verma
President & CEO, Cipla North America
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Marc Falkin
Executive Vice President / Chief Commercial Officer
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Company data provided by crunchbase