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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

Job Overview

TheManufacturingDocumentation Specialistis responsible forthecreation 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:

\n
Workswith Manufacturing/Packagingto delivertimelybatch record review across all shifts.
\n

\n
Reviewsand approval of master batch records.
\n

\n
Develops appropriatedispositionmetrics, works with manufacturing/packagingpersonnel to achieve said targets. Generates and reports on metrics on agreed frequency
\n

\n
Createstraining materials for subject matter input.
\n

\n
Track and manage periodic review of approved procedures.
\n

\n
Developstrategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.
\n

\n
Provides data to support management evaluation of performance trends.
\n

\n
Owns quality records (change control, CAPA's, deviations) and delivers toestablishedtimelines.
\n

\n
Autonomously leadsand managesprojects to implement continuous improvement opportunities.
\n

\n
Lead and/or support root cause investigations related to performance trends and formal deviations.
\n

\n
Develop,implementand assess solutions for complex problems.
\n

\n
Anticipatesrisk andbuildscontingencies to help mitigate impact.
\n

\n
Reviewsdocument for accuracy and completeness.
\n

\n
Defendsthevalidationprograms and strategies tocustomersand regulatory auditors.
\n

\n
Performs weekly quality reviews of MasterControl database by assuring new documents have been entered usingappropriate protocols.
\n

\n
Followsstrict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP),complying withlegal regulations,monitoringthe environment.
\n

\n
Performs other duties as assigned.
\n

Education and Experience

\n
Associate degree with1-3yearsknowledge and experience of GMP documentationrequired.
\n

\n
Bachelor's degree inscience, biochemistry,pharmaceuticalengineering, PharmaceuticalSciences,or relateddisciplinefrom an accredited college/universitypreferred.
\n

\n
Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
\n

\n
Minimum one (1)yeardocumentation experience andthree(3) years related pharmaceutical or biotech industry experience.Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
\n

\n
Here'sa cleanedup, streamlined version that removes redundancy, tightens language, and groups related requirements while keeping the original intent and scope. This is suitable for an HRready job description.
\n

Technical Knowledge and Computer Systems Skills

\n
Proficient in Microsoft Office Suite, with intermediate skills in Word and Excel.
\n

\n
Strong organizational and timemanagement skills with the ability to prioritize multiple tasks in alignment with departmental and sitewide objectives.
\n

\n
Ability to work independently as a selfstarter and collaboratively within a dynamic, crossfunctional, teambased environment.
\n

\n
Demonstrated attention to detail, strong analytical skills, and solid basic math proficiency.
\n

\n
Ability to read, write, and communicate effectively in English.
\n

\n
Flexible and adaptable, with the ability to thrive in a fastpaced manufacturing environment and adjust quickly to changing priorities and schedules.
\n

GMP, Compliance, and Quality Systems Knowledge

\n
Working knowledge of pharmaceutical manufacturing operations and associated documentation.
\n

\n
Knowledge and handson experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and Standard Operating Procedures (SOPs).
\n

\n
Experience writing, revising, and creating cGMP records, SOPs, batch records (BMR/eBMR),eLogbooks, and documentation templates.
\n

\n
Knowledge and handling of deviations, CAPAs, change controls, FMECA, OOS, OOT, training records, and OOAC.
\n

\n
Experience supporting compliance activities, including participation in local and federal regulatory audits.
\n

\n
Ability tofacilitateproblem solving and root cause investigations, and to develop, implement, and assess solutions to complex issues.
\n

\n
Responsible for closure of compliancerelated CAPAs.
\n

Systems, Data, and Planning

\n
Experience with electronic quality and document management systems such as SAP,MasterControl, andTrackWisepreferred.
\n

\n
Ability to understand, analyze, and interpret complex data sets; experience with statistical analysis tools is a plus.
\n

\n
Knowledge of batch planning and executionin accordance withproduction plans.
\n

\n
Experience withdryproducts (DPI) is a plus.
\n

Benefits

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.

$\"Shape\"$ 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 byconsolidatingand 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 hasemergedas 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 isan anticipatedbase 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.

","shortDescription","

NOTICE: The posting for local applicants only - is not for those applying for...","promoted","title","Documentation Specialist - DPI","duration","Full Time","experienceLevel","","displayThumbnail","location","locations",[65],"id",["B","3081305710"],"displayHeadline","Work at Cipla USA","category","Writing & Editing","displayPublishedAt","3 days ago","displayUrl","/jobs/3081305710-documentation-specialist-dpi","shortTitle","shortLocation","Hauppauge, NY, United States","searchCompanyPath","/jobs?keyword=Cipla+USA","searchLocationPath","/jobs?location=Hauppauge%2C+NY%2C+United+States","searchTitlePath","/jobs?keyword=Documentation+Specialist+-+DPI",{"_66":67,"_68":69,"_70":71,"_72":73,"_74":75},"country","United States","city","Hauppauge","formatted","Hauppauge, NY, United States, 11788","state","NY","postal_code","11788",["D",1775953010000],"Omni Inclusive","Document Writer

Location: Seattle-Dexter, WA Hybrid\nTop Skills:\nAdvanced proficiency in Microsoft Office programs\nHS diploma or equivalent required. College or university degree preferred\nExperience with processing changes through VIVA management system preferred\nThis opportunity will support the documentation control and management of Cell Ther...

","Document Writer

Location: Seattle-Dexter, WA Hybrid\nTop Skills:\nAdvanced proficiency in Microsoft Office programs\nHS diploma or equivalent...","Manufacturing - Document Writer Job at Omni Inclusive in Seattle",[90],["B","3166253317"],"Work at Omni Inclusive","1 hours ago","/jobs/3166253317-manufacturing-document-writer-job-at-omni-inclusive-in-seattle","Seattle, WA, United States","/jobs?keyword=Omni+Inclusive","/jobs?location=Seattle%2C+WA%2C+United+States","/jobs?keyword=Manufacturing+-+Document+Writer+Job+at+Omni+Inclusive+in+Seattle",{"_66":67,"_68":91,"_70":92,"_72":93,"_74":94},"Seattle","Seattle, WA, United States, 98101","WA","98101",["D",1775953010000],"Actalent","

Technical Writer

We are seeking a dedicated Technical Writer to join our team and support the Manufacturing group. This role involves creating and maintaining Batch records and FDA submittal documents, ensuring compliance with industry standards.

Responsibilities:

Develop and maintain Batch records and FDA submittal documents for the Manufacturing group.
Ensure all documentation complies with GMP and GLP standards.
Collaborate with regulatory and manufacturing teams to gather and interpret technical information.
Edit and review documents for accuracy and clarity.
Maintain document control processes and ensure consistency across all documentation.
Provide word processing support for Batch Records.

Essential Skills:

Proficiency in GMP, GLP, and manufacturing documentation standards.
Strong technical writing and editing skills.
Experience with document control and regulatory documentation.
Proficiency in Microsoft Office Suite, including word processing and editing.

Additional Skills & Qualifications:

Experience in regulatory environments is preferred.
Strong attention to detail and organizational skills.

Work Environment:

The role involves working closely with the manufacturing and regulatory teams, requiring a high level of collaboration and communication. The work environment is fast-paced and detail-oriented, ensuring all documentation meets strict compliance standards.

Job Type & Location:

This is a Contract position based out of Redmond, WA.

Pay and Benefits:

The pay range for this position is $35.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).

Workplace Type:

This is a fully onsite position in Redmond, WA.

Application Deadline:

This position is anticipated to close on Apr 15, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACwith four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands.

","

Technical Writer

We are seeking a dedicated Technical Writer to join our team and support the Manufacturing group. This role involves c...","Actalent is hiring: Technical Writer in Redmond",[108],["B","3193035487"],"Work at Actalent","/jobs/3193035487-actalent-is-hiring-technical-writer-in-redmond","Redmond, WA, United States","/jobs?keyword=Actalent","/jobs?location=Redmond%2C+WA%2C+United+States","/jobs?keyword=Actalent+is+hiring%3A+Technical+Writer+in+Redmond",{"_66":67,"_68":109,"_70":110,"_72":93,"_74":111},"Redmond","Redmond, WA, United States, 98052","98052",["D",1775646000000],"Technical Writer

We are seeking a dedicated Technical Writer to join our team and support the Manufacturing group. This role involves creating and maintaining Batch records and FDA submittal documents, ensuring compliance with industry standards.\nResponsibilities:\nDevelop and maintain Batch records and FDA submittal documents for the Manufacturing group.\nEnsure all documentation complies with GMP and GLP standards.\nCollaborate with regulatory and manufacturing teams to gather and interpret technical information.\nEdit and review documents for accuracy and clarity.\nMaintain document control processes and ensure consistency across all documentation.\nProvide word processing support for Batch Records.\nEssential Skills:\nProficiency in GMP, GLP, and manufacturing documentation standards.\nStrong technical writing and editing skills.\nExperience with document control and regulatory documentation.\nProficiency in Microsoft Office Suite, including word processing and editing.\nAdditional Skills & Qualifications:\nExperience in regulatory environments is preferred.\nStrong attention to detail and organizational skills.\nWork Environment:\nThe role involves working closely with the manufacturing and regulatory teams, requiring a high level of collaboration and communication. The work environment is fast-paced and detail-oriented, ensuring all documentation meets strict compliance standards.\nJob Type & Location:\nThis is a Contract position based out of Redmond, WA.\nPay and Benefits:\nThe pay range for this position is $35.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).\nWorkplace Type:\nThis is a fully onsite position in Redmond, WA.\nApplication Deadline:\nThis position is anticipated to close on Apr 15, 2026.\nDiversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:\nHiring diverse talent\nMaintaining an inclusive environment through persistent self-reflection\nBuilding a culture of care, engagement, and recognition with clear outcomes\nEnsuring growth opportunities for our people\nActalent is an equal opportunity employer.\nAbout Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACwith four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.\nOur Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands.\n","Technical Writer

We are seeking a dedicated Technical Writer to join our team and support the Manufacturing group. This role involves crea...","Technical Writer",[120],["B","3198417067"],"/jobs/3198417067-technical-writer","/jobs?keyword=Technical+Writer",{"_66":67,"_68":109,"_70":110,"_72":93,"_74":111},["D",1775953010000],"

Manufacturing Tech Writer

The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the do...

","

Manufacturing Tech Writer

The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows...","Omni Inclusive is hiring: Technical Writer in Bothell",[131],["B","3193034208"],"/jobs/3193034208-omni-inclusive-is-hiring-technical-writer-in-bothell","Bothell, WA, United States","/jobs?location=Bothell%2C+WA%2C+United+States","/jobs?keyword=Omni+Inclusive+is+hiring%3A+Technical+Writer+in+Bothell",{"_66":67,"_68":132,"_70":133,"_72":93,"_74":134},"Bothell","Bothell, WA, United States, 98021","98021",8752,"name","Newsday Media Group","agency","logo","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/351727.GIF","slug","newsday-media-group","

Newsday Media Group is a locally owned, independent media company grounded in journalistic excellence, integrity, and commitment to the communities it serves. With 19 Pulitzer Prizes and dozens of Emmy Awards, it's one of the most decorated news organizations in the country.

The company is in the middle of a significant transformation, expanding from its newspaper roots into a multimedia operation spanning digital, video, podcasts, live events, and data-driven civic engagement. NMG properties include the flagship Newsday and Newsday.com, NewsdayTV, the Newsday Live events series, and nextLI, a civic research and community forum platform funded by The Rauch Foundation.

A new 130,000-square-foot headquarters in Melville features a broadcast-quality TV studio and multimedia production space. Newsday Live produces a growing calendar of food and wine tastings, author talks, sports Q&As, concerts, and community events. Feed Me, the company's food and dining vertical, includes a web series, quarterly print magazine, and restaurant coverage. Brand 360, the in-house content studio, partners with advertisers across healthcare, education, energy, tourism, and retail.

Newsday's investigative unit has driven real-world change, from prompting schools to replace unsafe football helmets to contributing reporting that led to federal corruption convictions. Community programs include the Newsday Marching Band Festival, CheerFest, Scholar-Artist honors, and partnerships with local nonprofits focused on hunger, housing, youth education, and child welfare.

For people who care about local journalism, multimedia storytelling, and community impact, Newsday is doing the work at scale.

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The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the do...\n","descriptionText","Technical Writer Omni Inclusive Writing & Editing Manufacturing Tech Writer The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the do...","Manufacturing Tech Writer

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