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QA QMS Lead - Investigations

Cipla USA
flexible benefit account, parental leave, paid time off, paid holidays, flex time, 401(k)
United States, New York, Central Islip
550 South Research Place (Show on map)
Jul 16, 2025

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

QMS Lead - Investigations

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY

Employment Type

Full Time a" Salary/Exempt

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 a" medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) a" 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.

Work Hours/ Shift/ Remote

8:30 AM a" 5:00 PM (General Shift)

Responsibilities/ Accountabilities

  • Lead of investigation team and involve in conducting thorough investigations related to Out of Specifications (OOS), Out of Trend (OOT), Deviations, complaints, and non-conformances to identify root causes.
  • Prepare, review and approve detailed investigation reports, including root cause analysis and corrective actions.
  • Work closely with QA, AQA, operations, quality control, and other departments to gather information and implement solutions.
  • Ensure the corrective action implementations to address identified issues and preventive actions to avoid recurrence.
  • Track the effectiveness of CAPA plans and maintain comprehensive records of CAPA activities and outcomes.
  • Oversee changes to processes, equipment, and systems to ensure they do not negatively impact product quality.
  • Conduct risk assessments for proposed changes and implement necessary controls. Ensure all changes are properly documented and approved according to regulatory requirements.
  • Create and enforce quality systems and procedures to ensure consistent product quality.
  • Identify opportunities for process improvements and implement changes to enhance quality and efficiency.
  • Resolve findings from internal and external audits, implementing corrective actions as needed.
  • Provide training sessions for team members on quality standards, procedures, and best practices.
  • Keep updated records of personnel training to ensure compliance and track competency.
  • Utilize QMS software like TrackWise and SAP to manage quality processes.
  • Ensure proper issuance, retrieval, and tracking of QMS documents across the site

Education Qualifications/Experience

  • Minimum batcher degree in Science, Pharmacy, or related field.
  • 5-8 years of relevant experience in pharmaceutical manufacturing, particularly in QA/QMS roles.
  • Strong knowledge of cGMP norms, root cause analysis, CAPA management, and proficiency in QMS software.

Skills

  • Ability to take independent decisions for disposition of investigations.
  • Ability to have technical writing skills related to QMS documents.
  • Knowledge of Good Manufacturing Practices and Good Documentation Practices.
  • Working knowledge in operation area.
  • Ability to work effectively in a cross-functional team environment.
  • Self-motivated, with the ability to work independently.
  • Excellent organizational and analytical skills with the ability to focus on details.
  • Experience with QMS Systems (TrackWise, Master Control, etc.).
  • Shall be abreast of regulatory guidelines such as CDER, CHRA, ICH, USP Monograph, etc.

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 Indiaas 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 aCaring for Lifea, Ciplaas 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 Ciplaas respiratory business in the United States.

Equal Opportunity Employer

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to 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.


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