Sr Quality Specialist, Systems

Senior Quality Specialist, Systems

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.

Scope of Authority (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 / 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 CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings

40%

Compliance

20%

20%

Management Review

15%

Continuous Improvement

5%

Total

100%

Qualifications

Education & Experience

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

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.

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.

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.

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.

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.