Sr Quality Specialist, Quality Systems
Senior Quality Specialist, Systems, Quality Assurance/Systems, Michigan-Rochester
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide. For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89. Learn more at www.endo.com.
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 makes 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.
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.
ROLE AND RESPONSIBILITIES:
- Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings
- 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
- Coordinates and prepares metrics and materials for Quality Council and Management Review
- Performs and evaluates CAPA effectiveness checks
Education & Experience
- 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
- 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
Skills & Abilities
- 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
- Walk across plant/warehouse
- Afternoon shift premium is 10% (non-union positions only)
- Midnight shift premium is 15% (non-union positions only)
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled