Jobs at Endo

The Senior Analyst in Quality Control performs analytical testing, documents data, ensures lab compliance, and maintains safety protocols. They handle method transfer and validation, manage laboratory documents, and initiate requests based on lab activities.

The Quality Assurance Tech II reviews batch records, ensures compliance, processes labeling, performs trending analysis, assists training, and aids production compliance in a cGMP facility.

Provide end-to-end order management and customer support, handling inbound/outbound communications, order entry, returns, credits, shipment tracking, export documentation, and coordination with sales, product, and distribution teams to resolve discrepancies and ensure timely, compliant deliveries.

This position involves analytical method development, qualification support for nitrosamines and impurities, and ensuring compliance with GLP/cGMP norms.

Provide technical support in a lab environment by performing analysis on materials, conducting investigations, and maintaining safe work standards. Peer-review work and train others.

As a Research Associate, the role involves analytical method development, qualification standards, and analytical support for impurity and nitrosamines synthesis. Ensuring compliance with GLP/cGMP, performing validations, and maintaining document integrity are key responsibilities.

The role involves developing, validating analytical methods for API testing, ensuring compliance with GMP, and performing method transfer and production support. Responsibilities include maintaining instruments, analyzing samples, and supporting quality management systems.

Lead EHS functions, ensuring compliance and sustainability programs, overseeing environmental operations, occupational health, and safety leadership; implement ISO standards and manage audits.

Provide technical support and manage maintenance of fixed equipment, ensuring adherence to standards. Conduct inspections and failure analysis, develop maintenance schedules, and manage capital projects.

The Research Associate will conduct lab experiments for API process development, feasibility studies, optimization, and synthesis of impurities while maintaining a safe lab environment.

Ensure QA compliance through document review and inspection in a cGMP environment, addressing discrepancies and supporting manufacturing operations.

The Research Associate will support analytical method development and qualification, handle queries related to impurity and nitrosamine qualification, ensure compliance with GLP/cGMP norms, and maintain analytical instruments and documentation.

Perform microbiological testing of raw materials, in-process, finished, stability, swab and water samples; conduct environmental monitoring; perform instrument calibration, media/culture handling, method transfers/validation; maintain auditable records and GLP/GDP compliance; initiate change requests; complete trainings and uphold 5S and safety practices.

Perform routine and stability analytical testing of drug products and raw materials using HPLC, GC, UV, and dissolution. Maintain and troubleshoot instruments, ensure cGMP/GLP and FDA data integrity compliance, investigate OOS/OOT, support CAPA and audits, and participate in method transfer, verification, and validation while preparing analytical reports and SOPs.

Plan and execute shopfloor in-process quality assurance (IPQA) activities, authorize line clearances, perform in-process inspections and sampling, manage reserve and stability samples, calibrate IPQC instruments, review batch records, post QA transactions in SAP, conduct maintenance impact assessments, and ensure cGMP and EMS compliance.

Lead and oversee site quality assurance activities including review and approval of validation protocols/reports, master and executed batch record review, cleaning validation, SOPs, investigations and root cause analysis, risk and impact assessments, hold time studies, new product introductions, self-inspections, and commercial dispatch per site schedule.

Perform routine analytical testing of in-process, hold time, finished product, and stability samples. Record and report data per cGLP and good documentation practices, maintain auditable records and lab compliance, initiate change requests, complete assigned training, and uphold safety and 5S standards.

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.

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.

Execute and oversee routine and complex analytical testing ensuring SOP, regulatory, and quality compliance. Interpret data, investigate OOS/OOT results, support method validation/transfer, maintain data integrity, mentor junior analysts, and coordinate with cross-functional teams to drive continuous improvement and meet project timelines.