Analyst, Global Stability

Posted 7 Days Ago
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Pudupakkam, Marakkanam, Viluppuram, Tamil Nadu, IND
In-Office
Mid level
Healthtech • Pharmaceutical • Telehealth
The Role
Perform routine QC testing and instrumental analyses (HPLC, GC, UV-Vis, Dissolution) on raw materials, intermediates, and finished products. Execute and support stability studies, method transfers/validations, OOS/OOT investigations, and CAPAs. Maintain GMP-compliant documentation, equipment calibration, and participate in audits and regulatory inspections while coordinating with QA, Manufacturing, and Regulatory Affairs.
Summary Generated by Built In

Job Description Summary

QC Analyst with 3–6 years of experience in pharmaceutical quality control, skilled in routine in‑process samples, and finished products. Experienced in instrumental analysis (HPLC, GC, UV, Dissolution), method execution as per approved SOPs, OOS/OOT investigations, and data integrity compliance. Well‑versed in GMP, documentation practices, and regulatory guidelines, with strong analytical and problem‑solving skills.

Job Description

  • Perform routine QC testing of raw materials, intermediates, and finished products using approved analytical methods.
  • Conduct instrumental analysis including HPLC, GC, UV–Vis, Dissolution, and wet chemistry techniques.
  • Execute stability studies, compile data, trend results, and prepare stability reports.
  • Review and ensure accuracy, completeness, and compliance of analytical data and documentation.
  • Handle OOS, OOT, deviations, and laboratory incidents, including root cause analysis and implementation of CAPAs.
  • Ensure compliance with cGMP, data integrity (ALCOA+), SOPs, and regulatory guidelines.
  • Support method transfers, method verifications, and analytical method validations as required.
  • Maintain laboratory equipment, perform calibrations, and ensure proper documentation of laboratory activities.
  • Participate in internal audits, regulatory inspections, and continuous improvement initiatives.
  • Coordinate with cross‑functional teams such as QA, Manufacturing, and Regulatory Affairs as needed.

  • Proficiency in laboratory documentation and electronic systems (LIMS preferred).
  • Good problem‑solving, analytical, and communication skills.
  • Ability to work independently as well as collaboratively in a regulated environment.

Skills Required

  • 3-6 years of experience in pharmaceutical quality control
  • Experience performing routine in-process and finished product testing
  • Instrumental analysis experience: HPLC, GC, UV-Vis, Dissolution
  • Execute methods per approved SOPs and support method transfers, verifications, and validations
  • Handle OOS/OOT investigations, deviations, root cause analysis, and implement CAPAs
  • Knowledge of cGMP, data integrity (ALCOA+), documentation practices, and regulatory guidelines
  • Proficiency in laboratory documentation and electronic systems
  • Experience with LIMS
  • Maintain and calibrate laboratory equipment and document activities
  • Participate in internal audits, regulatory inspections, and continuous improvement initiatives
  • Strong problem-solving, analytical, and communication skills; ability to work independently and collaboratively in regulated environment

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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