Sr. Quality Specialist, Systems

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, Systems monitors, tracks, and trends Non-Conformances, CAPA, Complaints and other quality systems, assesses the risk level associated with Non-Conformances and escalates the issue to management. Gathers, analyzes, reports and presents metrics to the Quality Systems and Technology Department for the corporate Quality Index. Reviews or approves the Site Quality Review for Complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours. May attend meetings in place of the Manager Quality Systems and determines priorities and make appropriate decisions.
The job requires coordination with different departments within the respective site as well as the Quality Systems and Technology department to ensure compliance to current Standard Operating Procedures for the quality systems defined within the corporation and government regulations.

Job Description

• Continuous Improvement

• Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings

• Compliance

• Assesses risk level associated with NCRs, notifies Planning/Scheduling, and escalates to management
• Reviews or approves Site Quality Reviews of complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours
• Attends meetings as requested in place of the Manager Quality Systems and determines priorities and makes appropriate decisions
• Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time
• Reviews current Quality Systems, works with cross functional teams and recommends improvements

• Management Review

• Coordinates and prepares metrics and materials for Quality Council and Management Review

• Continuous Improvement

• Performs and evaluates CAPA effectiveness checks
• BA/BS preferably in life sciences plus a minimum of 6+ years’ experience in the pharmaceutical industry OR
• MS +4 years’ relevant experience in pharmaceutical industry

• Proficiency in a body of information required for the job

  e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA
• Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
• Technical and quality background related to pharmaceuticals

• Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Strong communication skills
• Strong focus on quality and proven ability to apply a high degree of integrity
• Customer/Stakeholder focused (understand business plans and operating environment)
• Technical Writing ability 
• Clear problem-solving and decision-making skill

• Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Walk across plant/warehouse

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.