Analyst, Global Stability

Posted 7 Days Ago
Be an Early Applicant
Pudupakkam, Marakkanam, Viluppuram, Tamil Nadu, IND
In-Office
Mid level
Healthtech • Pharmaceutical • Telehealth
The Role
Perform routine and stability analyses of drug products and raw materials using HPLC, GC, UV, and dissolution. Operate and maintain instruments, review and document analytical data under cGMP/GLP, investigate OOS/OOT, support CAPA and deviations, prepare reports/SOPs, and assist with method transfer, validation, and regulatory/internal audits to ensure compliance with FDA requirements.
Summary Generated by Built In

Job Description Summary

Experienced Analytical/Quality Control Analyst with 3–5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.

Job Description

  • Perform routine and stability sample analysis as per approved specifications and test methods
  • Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
  • Review and document analytical data in compliance with cGMP and data integrity principles
  • Investigate OOS/OOT results and support deviation and CAPA activities
  • Ensure compliance with FDA, cGMP, and GLP requirements
  • Prepare and review analytical reports, protocols, and SOPs
  • Participate in method transfer, verification, and validation activities
  • Support regulatory and internal audits

Key Skills:

  • Strong knowledge of FDA regulations, cGMP, and data integrity
  • Analytical troubleshooting and problem-solving skills
  • Documentation and compliance expertise
  • Team collaboration and communication

Skills Required

  • 3-5 years hands-on experience in an FDA-regulated pharmaceutical environment.
  • Proven experience performing analytical testing of drug products and raw materials using HPLC, GC, UV, and dissolution.
  • Experience handling stability samples and performing routine stability analyses per approved methods.
  • Strong knowledge of cGMP, GLP, FDA regulatory requirements, and data integrity principles.
  • Ability to operate, maintain, and troubleshoot analytical laboratory instruments (HPLC, GC, UV, dissolution apparatus).
  • Experience investigating OOS/OOT results and supporting deviation and CAPA activities.
  • Experience preparing and reviewing analytical reports, protocols, and SOPs; participating in method transfer, verification, and validation.
  • Experience supporting regulatory and internal audits and inspections.

Endo Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Endo and has not been reviewed or approved by Endo.

  • Fair & Transparent Compensation Pay is considered competitive to good across many roles, with total compensation in commercial positions strengthened by sizable bonus/OTE when targets are met. Subsidiary experiences within the group also point to good compensation, reinforcing a generally positive pay story.
  • Healthcare Strength Core medical, dental, and vision coverage is strong, complemented by virtual care, disease‑management programs, and a health advocate service. Health coverage is described as good, adding perceived value beyond base pay.
  • Retirement Support A 401(k) plan provides a company match up to 4%, supporting employees’ long‑term savings. Current materials outline the matching formula clearly for prospective comparisons.

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The Company
HQ: İzmir
1,722 Employees
Year Founded: 1997

What We Do

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.

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