QA Manager, Auditor

Quality Assurance

Reporting To: Senior Director, QA

Responsibilities

• • The primary responsibility of the QA Auditor will be to conduct internal and supplier audits as assigned. The QA Auditor will implement and maintain the Vendor Management program within our company and educate departments cross functionally in the requirements of the program.
• • Schedule and conduct audits of our external suppliers to ensure they meet current global regulations and acceptable GXP quality standards.
• • Draft and distribute audit reports within assigned time frames and work with external organizations to ensure appropriate follow up to all audit findings.
• • Schedule and conduct internal audits of GXP regulated departments within the company as well as write and distribute audit reports while working collaboratively with internal departments to ensure timely and appropriate responses to audit findings.
• • Assist with implementation of our internal supplier assessment program. Duties may include creating/revising controlled documentation such as SOPs, Forms, and Vendor Questionnaires; scheduling cross functional team meetings; working with vendors to obtain completed questionnaires; and leading the assessment process for external suppliers.

Qualifications

• At least 3 years experience working in GMP Pharmaceutical environment
• Knowledge and understanding of FDA, EMA, and ICH Regulations
• Minimum 2 years of auditing experience preferred
• Ability to work collaboratively in a team environment and communicate cross-functionally
• Ability to travel domestically and internationally (travel up to 25%)
• Experience with vendor management and continuous improvement initiatives desirable
• Top notch writing skills
• BS degree
• CQA preferred (Certified Quality Auditor)

CPC is offering a professional, stable work environment with excellent opportunity for career growth in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, ife insurance, paid time-off, and 401(k) plan.