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About the Role

This role involves preparing and reviewing various technical documents, supporting investigations and validation activities, and applying process improvement strategies to enhance packaging operations. The specialist will also perform data analysis, ensure compliance and clarity in documentation, and contribute to root cause analysis for process improvements within a pharmaceutical manufacturing setting.

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.
• Apply process improvement strategies and lean techniques to analyze and improve 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.
• Follow documented SOPs for creating and storing documents.
• Work independently and collaboratively.
• Analyze data to make recommendations and monitor performance.
• Perform administrative functions 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.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA’s Safety, Health, and Environmental policies.
• Work under general supervision and in a team environment.
• Exercise appropriate professional judgment on matters of significance.
• Work in a pharmaceutical manufacturing setting.
• Perform other duties as assigned by Manufacturing Management.

Requirements

• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.
• Preference for candidates with experience in generic pharmaceutical manufacturing.
• Must be able to work under general supervision.
• Must be 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.

Skills

• 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
• Strong documentation and technical writing skills
• Ability to apply relevant scientific principles and practices
• Communicate clearly and concisely across levels, both orally and in written
• Strong command over written and verbal English

Location

• Central Islip, NY
• Hauppauge, NY

Work Type

• Hourly
• Full Time
• Onsite

Experience Level

• 1-3 years

Education Level

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

Salary/Compensations

• $20.00-$26.00 per hour

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

About the Company

• Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines.
• 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.

Equal Opportunity

• Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
• Cipla welcomes people of all abilities and wants to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.