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 SummaryMember of the Quality group providing support for various aspects of Development, Phase I-IV clinical, scale-up activities and commercial manufacturing, testing and release, as applicable. The Quality Specialist assists with internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable, and helps assure compliance with current domestic and international GMPs and regulatory agencies. The Quality Specialist may monitor, track and trend Non-Conformances, CAPA and other quality systems, assesses the risk level associated with Non-Conformances and escalate the issue to management. This role is responsible for initiating self-audit checks and evaluation of CAPA effectiveness checks. Additionally, the Quality Specialist is responsible for preparing materials for inspection readiness and management review.Job DescriptionResponsibilitiesQuality Documentation/Report Review
Prepares and/or reviews controlled documents (e.g. SOP’s) required for compliance.
Completes assigned duties and responsibilities (filing, etc.).
Assists with decisions that require developing options to solve basic to moderate issues.
Quality Systems
Assesses risk level associated with NCRs, and escalates to management.
Assists with various aspects of 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.
Initiates communication of due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time.
Contributes to various aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.
Continuous Improvement
Initiates self-audit checks and evaluates CAPA effectiveness checks.
Inspection Readiness
Prepares materials for inspection readiness and management review.
QualificationsEducation & Experience
Associate’s degree in science or engineering with 5+ years’ experience in pharmaceutical / biopharmaceutical industry OR
Bachelor’s degree in above fields with 3+ years’ experience in pharmaceutical / biopharmaceutical industry OR
Master’s degree in above fields with 1+ years’ experience in pharmaceutical / biopharmaceutical industry.
Knowledge
Working knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA.
Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
Technical and quality background related to pharmaceuticals.
General 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 relationships.
Physical Requirements
Routine office work (sit/stand); no travel requirements.
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.EEO Statement:At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
