Sr. Quality Specialist, Systems

Posted Yesterday
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Rochester, MI
5-7 Years Experience
Healthtech • Pharmaceutical • Telehealth
The Role
The Senior Quality Specialist, Systems monitors and analyzes quality systems, tracks Non-Conformances and Complaints, and ensures compliance with regulations. The role involves preparing metrics for Quality Management Review and coordinating with various departments to drive continuous improvement in quality processes.
Summary Generated by Built In

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.

The Company
Montreal, Quebec
1,722 Employees
On-site Workplace
Year Founded: 1997

What We Do

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.

Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.

Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.

Endo has global headquarters in Malvern, Pennsylvania.

Community Guidelines:
1. Be respectful. Everyone who visits our page should feel comfortable and respected.
2. If we see a comment that violates anything in the following list, it may be removed.
• Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional.
• Comments that are excessively repetitive and/or disruptive to the community.
• Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter.
• Comments that appear to be medical advice.
We reserve the right to remove a reply for any reason at any time.
3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088.

Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.

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