Senior Quality Specialist

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

Member of the Quality group providing support for all aspects of Development, Phase I-IV clinical, scale-up activities and commercial manufacturing, testing and release, as applicable. Supports internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable. Assures compliance with current domestic and international GMPs and regulatory agencies. This role contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures. The Senior Quality Specialist will assist in decision making that requires developing options to solve moderate to complex issues.

Job Description

Responsibilities:

Batch Record/Reports Review

• Supports the QA batch release functions for cGMP commercial, clinical, and development manufacturing and distribution activities from the local, contract manufacturing, filling, and packaging facilities.

Quality Documentation/Reports Review

• Contributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
• Releases consumables and raw materials used in the manufacturing process and drug substances/drug product.
• Assists with decisions that require developing options to solve moderate to complex issues.

Quality Documentation

• Prepares and/or reviews controlled documents (e.g. SOPs) required for compliance.

Quality Systems & CAPA Investigations

• Contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities.

• Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.

Quality Documentation

• Contributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
• Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes or services.

Inspection Readiness

• Participates in cross functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects.

Qualifications

Education & Experience

• Associate’s degree in science or engineering with 7+ years’ experience in pharmaceutical / biopharmaceutical industry OR
• Bachelor’s degree in above fields with 5+ years’ experience in pharmaceutical / biopharmaceutical industry OR
• Master’s degree in above fields with 3+ years’ experience in pharmaceutical / biopharmaceutical industry OR
• PhD in above fields with 1+ years’ experience in pharmaceutical / biopharmaceutical industry.
• Industry experience with aseptic operations, CMO, CTL and packaging/labeling required.

Knowledge

• Strong knowledge of the principles, concepts and theories of the compliance/QA discipline.
• Advanced knowledge in QA discipline(s) (e.g., Change Control, Investigation, etc.).
• Deep understanding and knowledge of cGMP regulations.

Skills & Abilities

• Strong verbal and communication skills required.
• Attention to detail required.
• Demonstrated excellent interpersonal skills and flexibility.
• Ability to handle multiple priorities in a fast-paced environment.
• Good writing skills.
• Strong organizational skills.
• Ability to build peer relationshi