NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates
Job Title: Documentation Specialist – MFG/PKG
Employment Type: Full Time / Exempt
Location: Central Islip / Hauppauge, NY
Work Hours: General Shift: 8:30AM – 5:00PM (may vary based on business needs)
Salary Range: $66,300-$86,000
The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP’s. In this role, the Documentation Specialist adheres to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity.
The job duties for this position include but are not limited to the following:
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Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
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Bachelor’s degree in science, biochemistry, pharmaceuticalengineering, Pharmaceutical Sciences, or related discipline from an accredited college/university preferred.
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Here’s a cleaned‑up, streamlined version that removes redundancy, tightens language, and groups related requirements while keeping the original intent and scope. This is suitable for an HR‑ready job description.
Technical Knowledge and Computer Systems Skills
GMP, Compliance, and Quality Systems Knowledge
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Knowledge and hands‑on experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and Standard Operating Procedures (SOPs).
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Experience writing, revising, and creating cGMP records, SOPs, batch records (BMR/eBMR), eLogbooks, and documentation templates.
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Knowledge and handling of deviations, CAPAs, change controls, FMECA, OOS, OOT, training records, and OOAC.
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Ability to facilitate problem solving and root cause investigations, and to develop, implement, and assess solutions to complex issues.
Systems, Data, and Planning
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.
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. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
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.
