Quality Assurance Lead
4 days ago
About Us
">Endo is a global leader in delivering life-enhancing products through focused execution. Our mission drives us to develop and deliver innovative solutions that improve patients' lives. We are committed to fostering a diverse, equitable, and inclusive workplace where talented individuals can thrive.
">Job Description Summary
">The Senior Quality Specialist leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. They provide quality guidance on product transfers and validations and ensure all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.
">Key Accountabilities
">- ">
- Quality Documentation/Reports Review:">
- ">
- Contributes to the preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.">
- Assists with decisions that require developing options to solve moderate to complex issues.">
- Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes, or services.">
- Prepares and/or reviews controlled documents (e.g., SOPs) required for compliance.">
- Provides quality guidance on product transfers and validations and ensures all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.">
- Quality Systems & Investigations:">
- ">
- Takes the lead in resolving investigations, deviations, and corrective actions, and other quality issues with each CMO.">
- Leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.">
- 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.">
- 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
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- Bachelor's degree in a scientific-related field with a minimum of 5-8 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.">
- Master's degree in above fields with 3-6 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry OR">
- Technical and quality background related to the sciences.">
- Background in sterile manufacturing 1-5 years.">
Knowledge and Skills
">- ">
- Strong knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).">
- Knowledge of 21-CFR-210, 21-CFR-211, and ICH Guidelines.">
- Strong knowledge of the principles, concepts, and theories of the compliance/QA discipline.">
- 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 relationships.">
Commitment to Diversity, Equity, and Inclusion
">At Endo, our diversity unites and empowers us as One Team. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity.
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