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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.
Job Description Summary
Independently organizes and performs quality audits under general direction. The audits include suppliers/vendors, third parties, Endo’s business units and internal manufacturing sites that support marketed drug products to ensure products, controls, policies and processes meet Pharmaceutical/Biotechnology industry quality standards. Participates in Pre-Approval Mock Inspections to prepare internal & CMO facilities for regulatory inspections and assesses gaps in the quality systems and overall infrastructure. Provides cGMP guidance for continuous improvement projects to ensure compliance with regulations and current industry standards. Assists in the evaluation of metrics to determine trends and opportunities for continuous improvements. Provides support during regulatory agency and external third party inspections. Possess sound technical knowledge and auditing experience in multiple areas, such as API, Analytical Laboratories, Sterile Drug Product, Contract Packaging, Mock PAI, etc.Job Description
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Responsibilities
85% of Time:
- Supports the audit program by independently conducting internal and external audits or participating as an audit team member
- Contributes to the development of the annual audit plans and schedules
- Schedules audit activities and provides audit agenda
- Prepares audit reports and communicates findings to external and internal stakeholders
- Tracks audit responses and auditee’s CAPAs through completion and closeout
- Expand technical knowledge and auditing experience as lead auditor across the range of branded product suppliers (i.e. API, Sterile Drug Product, Mock PAI, etc.)
- Support collection and collating of applicable key auditing performance parameters in contribution of reporting metrics
15% of Time:
As related to Enterprise Quality Auditing Functions:
- Provides guidance for continuous improvement to ensure compliance with regulations and current industry standards
- Assists in the evaluation of metrics to determine trends and opportunities for continuous improvements
- Participates in the development and implementation of EQA programs, policies, procedures, agreements & controls
- Participates in periodic audit review meetings
- Supports regulatory agency and external third party audits
- Participates in Mock PAIs of internal sites & CMOs to prepare for audits and assess gaps in the system
Compensation & Benefits:
Endo proudly offers a competitive package of total rewards to our team members, which include the compensation and robust offering of benefits described below.
The base pay target range for this position is indicated below. The selected candidate will be eligible to participate in a bonus program. The amounts of compensation under the company’s incentive compensation programs, if any, may depend on a variety of factors, including individual and/or company performance. Eligibility for such programs is subject to change.
Endo also offers a variety of benefits, which include medical insurance; dental insurance; vision insurance; optional supplemental medical insurance; health savings and flexible spending accounts; company-paid life insurance and additional voluntary life insurance; company-paid short-term disability and long-term disability insurance; a 401(k) savings and investment plan with discretionary match; and paid time off / holidays, determined in accordance with the company’s policies. Endo will also comply with any applicable state and local laws*. All benefit offerings and eligibility are subject to applicable plan terms and the company’s policies, which are subject to change.
Annual Base Pay Range**: $105,000 - $152,250
* Including, but not limited to, providing time off pursuant to the Colorado Healthy Families and Workplaces Act in accordance with its policies.
** Actual base pay may differ depending on a variety of factors including, but not limited to, the selected candidate’s level of experience, skills, education, geographic location and/or, in the case of non-exempt roles, the number of hours worked (for non-exempt roles, the Annual Base Pay Range above is based on 2,080 hours per year).
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.
