Assistant Documentation Specialist

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

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.

Education Qualifications

BA/BS degree in a related field of study from an accredited college/university required.

Experience

One (1) to three (3) years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic 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.

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 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, and other benefits.

About Cipla

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 the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose of ‘Caring for Life’, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.

About the Salary/ Pay Range

The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.