Documentation Specialist - DPI
Cipla USA, Hauppauge, NY, United States
NOTICE: The posting is for local applicants only. Do not apply for a global assignment or if you work 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: 8:30 AM – 5:00 PM (may vary based on business needs)
Salary Range:
$66,300 – $86,000
Job Overview The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOPs. In this role, the Documentation Specialist adheres to the company’s document and SOP procedures while ensuring their accuracy, quality, and integrity.
Responsibilities
Work with Manufacturing/Packaging to deliver timely batch record review across all shifts.
Review and approve master batch records.
Develop appropriate disposition metrics, work with manufacturing/packaging personnel to achieve said targets, and generate and report on metrics on an agreed frequency.
Create training materials for subject matter input.
Track and manage periodic review of approved procedures.
Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.
Provide data to support management evaluation of performance trends.
Own quality records (change control, CAPA's, deviations) and deliver within established timelines.
Autonomously lead and manage projects to implement continuous improvement opportunities.
Lead and/or support root cause investigations related to performance trends and formal deviations.
Develop, implement, and assess solutions for complex problems.
Anticipate risk and build contingencies to mitigate impact.
Review documents for accuracy and completeness.
Defend validation programs and strategies to customers and regulatory auditors.
Perform weekly quality reviews of the MasterControl database, ensuring new documents are entered using appropriate protocols.
Follow strict internal protocols and SOPs, as well as current Good Manufacturing Practices (cGMP), complying with legal regulations and monitoring the environment.
Perform other duties as assigned.
Education and Experience
Associate degree with 1–3 years of knowledge and experience of GMP documentation required.
Bachelor’s degree in science, biochemistry, pharmaceutical engineering, pharmaceutical sciences, or a related discipline from an accredited college/university preferred.
Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field from an accredited college/university preferred.
Minimum one year documentation experience and three years related pharmaceutical or biotech industry experience. Preference to candidates with experience in generic pharmaceutical manufacturing.
Technical Knowledge and Computer Systems Skills
Proficient in Microsoft Office Suite, with intermediate skills in Word and Excel.
Strong organizational and time‑management skills with the ability to prioritize multiple tasks in alignment with departmental and sitewide objectives.
Ability to work independently as a self‑starter and collaboratively within a dynamic, cross‑functional, team‑based environment.
Demonstrated attention to detail, strong analytical skills, and solid basic math proficiency.
Ability to read, write, and communicate effectively in English.
Flexible and adaptable, with the ability to thrive in a fast‑paced manufacturing environment and adjust quickly to changing priorities and schedules.
GMP, Compliance, and Quality Systems Knowledge
Working knowledge of pharmaceutical manufacturing operations and associated documentation.
Knowledge and hands‑on experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and SOPs.
Experience writing, revising, and creating cGMP records, SOPs, batch records, eLogbooks, and documentation templates.
Knowledge and handling of deviations, CAPAs, change controls, FMECA, OOS, OOT, training records, and OOC.
Experience supporting compliance activities, including participation in local and federal regulatory audits.
Ability to facilitate problem solving and root cause investigations, and to develop, implement, and assess solutions to complex issues.
Responsible for closure of compliance‑related CAPAs.
Systems, Data, and Planning
Experience with electronic quality and document management systems such as SAP, MasterControl, and TrackWise preferred.
Ability to understand, analyze, and interpret complex data sets; experience with statistical analysis tools is a plus.
Knowledge of batch planning and execution in accordance with production plans.
Experience with dry products (DPI) is a plus.
Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package that includes 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, Cipla has strengthened its leadership in India’s pharmaceutical industry and expanded its global presence. Driven by the purpose of “Caring for Life,” Cipla’s focus is on making affordable, world‑class medicines with uncompromising quality standards.
InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines. It is based in Central Islip and Hauppauge, New York.
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, 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 may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and a bonus program based on performance and company results.
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Job Title:
Documentation Specialist – MFG/PKG
Employment Type:
Full Time / Exempt
Location:
Central Islip / Hauppauge, NY
Work Hours:
General Shift: 8:30 AM – 5:00 PM (may vary based on business needs)
Salary Range:
$66,300 – $86,000
Job Overview The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOPs. In this role, the Documentation Specialist adheres to the company’s document and SOP procedures while ensuring their accuracy, quality, and integrity.
Responsibilities
Work with Manufacturing/Packaging to deliver timely batch record review across all shifts.
Review and approve master batch records.
Develop appropriate disposition metrics, work with manufacturing/packaging personnel to achieve said targets, and generate and report on metrics on an agreed frequency.
Create training materials for subject matter input.
Track and manage periodic review of approved procedures.
Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.
Provide data to support management evaluation of performance trends.
Own quality records (change control, CAPA's, deviations) and deliver within established timelines.
Autonomously lead and manage projects to implement continuous improvement opportunities.
Lead and/or support root cause investigations related to performance trends and formal deviations.
Develop, implement, and assess solutions for complex problems.
Anticipate risk and build contingencies to mitigate impact.
Review documents for accuracy and completeness.
Defend validation programs and strategies to customers and regulatory auditors.
Perform weekly quality reviews of the MasterControl database, ensuring new documents are entered using appropriate protocols.
Follow strict internal protocols and SOPs, as well as current Good Manufacturing Practices (cGMP), complying with legal regulations and monitoring the environment.
Perform other duties as assigned.
Education and Experience
Associate degree with 1–3 years of knowledge and experience of GMP documentation required.
Bachelor’s degree in science, biochemistry, pharmaceutical engineering, pharmaceutical sciences, or a related discipline from an accredited college/university preferred.
Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field from an accredited college/university preferred.
Minimum one year documentation experience and three years related pharmaceutical or biotech industry experience. Preference to candidates with experience in generic pharmaceutical manufacturing.
Technical Knowledge and Computer Systems Skills
Proficient in Microsoft Office Suite, with intermediate skills in Word and Excel.
Strong organizational and time‑management skills with the ability to prioritize multiple tasks in alignment with departmental and sitewide objectives.
Ability to work independently as a self‑starter and collaboratively within a dynamic, cross‑functional, team‑based environment.
Demonstrated attention to detail, strong analytical skills, and solid basic math proficiency.
Ability to read, write, and communicate effectively in English.
Flexible and adaptable, with the ability to thrive in a fast‑paced manufacturing environment and adjust quickly to changing priorities and schedules.
GMP, Compliance, and Quality Systems Knowledge
Working knowledge of pharmaceutical manufacturing operations and associated documentation.
Knowledge and hands‑on experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and SOPs.
Experience writing, revising, and creating cGMP records, SOPs, batch records, eLogbooks, and documentation templates.
Knowledge and handling of deviations, CAPAs, change controls, FMECA, OOS, OOT, training records, and OOC.
Experience supporting compliance activities, including participation in local and federal regulatory audits.
Ability to facilitate problem solving and root cause investigations, and to develop, implement, and assess solutions to complex issues.
Responsible for closure of compliance‑related CAPAs.
Systems, Data, and Planning
Experience with electronic quality and document management systems such as SAP, MasterControl, and TrackWise preferred.
Ability to understand, analyze, and interpret complex data sets; experience with statistical analysis tools is a plus.
Knowledge of batch planning and execution in accordance with production plans.
Experience with dry products (DPI) is a plus.
Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package that includes 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, Cipla has strengthened its leadership in India’s pharmaceutical industry and expanded its global presence. Driven by the purpose of “Caring for Life,” Cipla’s focus is on making affordable, world‑class medicines with uncompromising quality standards.
InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines. It is based in Central Islip and Hauppauge, New York.
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, 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 may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and a bonus program based on performance and company results.
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