Job Title Senior Quality Specialist, Analytical & Stability Services Company Endo Ventures

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

The Senior Quality Specialist, Analytical & Stability Services represents Quality in full lifecycle projects and project teams to ensure that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs. Primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. This position will have a significant role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives. Writes and reviews SOPs, test methods, validation protocols and validation reports. Coaches and provides technical guidance to more junior specialists in root cause analysis, test methodology, and analytical techniques.

Job Description

The Senior Quality Specialist, Analytical & Stability Services represents Quality in full lifecycle projects and project teams to ensure that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs. Primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. This position will have a significant role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives.  Writes and reviews SOPs, test methods, validation protocols and validation reports.  Coaches and provides technical guidance to more junior specialists in root cause analysis, test methodology, and analytical techniques.

Responsibilities:

• Represents Quality in full lifecycle projects and project teams to ensure that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs.
• Provides counsel on cGMP requirements, with the ability to interpret regulations, guidance, and internal policies and apply them in the context of compliant execution.
• Makes QA decisions based on knowledge/interpretation of government regulations, guidelines and industry standards, risk based assessments, and internal policies.
• Reviews and approves laboratory test data and documentation for completeness and compliance, when necessary, in support of Third Party and Stability Testing.
• Responsible for maintaining Elemental Impurity compliance for finished goods.
• Writes and reviews SOPs, test methods, validation protocols and validation reports.
• Leads investigations for stability, OOS and other critical Laboratory events.
• Evaluates questionable sample results, OOS, and aberrant results and recommends a course of action.
• Works with Third Parties or other staff to ensure resolution of investigations, deviations, and corrective actions, etc.

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.