Lead Auditor and Quality Specialist

Description

Our mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of its materials.

Our focus is on building strong partnerships between pharmaceutical manufacturers and suppliers. Rx-360's goal is to ensure the integrity of supply chains through member-led working groups and audit programs.

We are a community of life-science and medical device thought leaders committed to driving positive change within the industry. 

We believe that aligning our actions with our mission leads to a meaningful and lasting impact on the industry and patients worldwide. Join us in advancing the future of supply chain integrity and patient safety.

Position Description

The Lead Auditor and Quality Specialist prepares for and conducts audits on behalf of Rx360. The person in this role is responsible for conducting audits of manufacturers in the pharmaceutical supply chain. The person in this role is responsible for reviewing and requesting key documents for review during the audit. Compile findings and recommendations into a formal audit report for review by the auditee, audit sponsor, and Rx360. Assists with the review and closure of CAPAs generated from audits.

This is a full-time position. 

Responsibilities/Duties

• Coordinate site visits with the auditee. Schedule the date(s) of the audit.
• Prepare for the audit by reviewing previous audit reports, CAPA plans, draft an audit plan, determine the scope of the audit, share and revise the audit plan as needed. 
• Conduct site audits that include touring the facility, a review of standard operating procedures, quality practices, employee training records, policies and procedures, and employee interviews. 
• Write audit reports that integrate and compile findings from the site visit and document review. 
• Coordinate accommodation and transportation for site visits. Travel to multiple sites to conduct the audits. 
• Assist with the review and closure of CAPAs generated from audits.
• Lead special projects as needed. 
• Assist in areas requiring insight and recommendations for the Quality team.

Requirements

• At least a bachelor's degree in environmental science & chemistry, biology, allied health, or life sciences.
• At least eight (8) years of experience auditing and implementing quality management systems for companies in the pharmaceutical, dietary supplements, cosmetic, medical devices, and food manufacturing industries.
• Able to travel up to 50-percent of the time for one - four days at one geographic location.

Skills, Knowledge, and Abilities

1. Analytical and decision-making abilities

2. Effective communication skills

3. Ability to write clearly and concisely.

4. Detail oriented

5. Understand auditing principles, methodologies, and standards.

6. Ability to work independently.

7. Able to travel for site visits.

Rx-360 offers medical, vision, and dental benefits. We also offer employer funded short-term disability, PTO days, and a retirement plan match up to 4%.