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.

The 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. Provides metrics to the Quality Systems and Technology Department for the corporate Quality Index. Work with the team in maintaining a collaborative environment.

The 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. Provides metrics to the Quality Systems and Technology Department for the corporate Quality Index. Works with the team in maintaining a collaborative environment.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Manages the Quality Systems at his/or her site as well as metrics, but may also assist other sites with metrics on an as needed basis

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Continuous Improvement

Monitors, tracks, and trends NCR, CAPA, and complaints, etc.

45%

Compliance

Assesses risk level associated with NCRs, notifies Planning/Scheduling, and escalates to management

20%

Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time

20%

Management Review

Assists in the preparation of materials for Quality Council and Management Review

10%

Continuous Improvement

Performs and evaluates CAPA effectiveness checks

5%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Minimum of BA/BS preferably in life sciences plus a minimum of 3+ years' experience in the pharmaceutical industry OR
• MS +1 year relevant experience in pharmaceutical industry.

Knowledge

Proficiency in a body of information required for the job

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

• Knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA

• Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines

• Technical and quality background related to pharmaceuticals

Skills

&

Abilities

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 Requirements

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

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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.