Lead Auditor Job in Rocky Mount 27801, North Carolina Us
Aspire...to save others' lives, while shaping your own.
What We Are Made Of
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.
The Rocky Mount operations has over 2500 employees and is one of the largest manufacturers of generic specialty injectables, including small and large volume parenterals, in the world. Rocky Mount offers a wide range of very rewarding and fulfilling careers. If you're a highly motivated individual with strong career aspirations and you believe your professional goals are in alignment with Hospira; then you're ready to advance wellness at the Rocky Mount operations.
What We Are Proud Of
We at Hospira, Inc. feel rewarded by our hard work and take pride in knowing we're on our individual career paths with a shared goal:
Advancing wellness™, through the right people and the right products
- People of integrity who are motivated by challenges, embrace diversity, embody our values and exude entrepreneurial spirit
- Products that are top quality, error reducing, technologically advanced, and most importantly, life saving
As an equal opportunity and affirmative action employer, Hospira, Inc. embraces diversity of thought and cultural perspective and fosters an environment of empowerment, fairness, and respect.
Why It's a Great Place
Employees are offered an agile yet balanced work atmosphere, incentive compensation and the benefits that you'd expect from an industry leader.
Health and welfare benefits
- Consumer-directed medical plan options - Health Reimbursement Account (HRA) and Health Savings Account (HSA) options that allow you the maximum flexibility in managing your health and health care spending
- Extensive preventive care benefits covered at 100%
- Dental plan
- Vision plan
- Flexible spending accounts - health care and dependent care
- Paid vacation and holidays
- Life insurance, short/long-term disability, ADD
- Optional long-term care insurance
- Adoption assistance
- Employee Assistance Program and work/life benefits
Generously matched 401(k) retirement savings plan
- Immediate vesting
- Numerous investment alternatives
- Loan provisions
Who You Can Become
At Hospira, Inc. you can have the opportunity to help continue our tradition of excellence, build upon it and contribute to its success. Empower yourself to use all of your skills to reach your goals - so that you can allow patients worldwide to reach theirs.
The Lead Auditor coordinates, administers, and implements the quality systems audit program to assure the product is manufactured in compliance with established regulations and Hospira quality policies. These activities include the development, implementation, and monitoring of quality auditing and associated activities to ensure the manufacture and distribution of pharmaceutical products are compliant with FDA regulatory requirements and foreign regulatory bodies. The Auditor organizes and leads a team of auditors for all internal audits. The Lead Auditor evaluates for root cause, assesses corrective actions, and works with site management to assure CAPA effectiveness.
Responsibilities include:
- Evaluates applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
- Supervises and assists Process Auditors in sustaining the facility's cGMP compliance by administering more cGMP audits throughout the facility on various shifts.
- Performs trending analysis of audit observations or compliance issues and address trending issues with appropriate personnel for resolution.
- Bachelor's Degree
- Drive to complete long term objectives
- Ability to work as a team member and/or leader of various projects
- Excellent written and oral communication skills
- ASQ certification 5 to 7 years of related experience in an FDA regulated work environment
