Quality / Compliance Auditor

About the position

Performing routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, providing compliance guidance and support throughout the Quality organization, training delivery, and leading multi-departmental teams and initiatives.

Responsibilities

• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assisting in implementing Internal Audit plans for all manufacturing plants.
• Assisting in implementing Supplier Audit plans for all manufacturing plants.
• Trends, analyses, and reports on quality data to improve product and process Quality for all plants; develop actions for improvement based on data analyses.
• Peer Review of Audits Reports.
• Provide support prior, during and post inspections for external Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensure the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keeping abreast of industry standards and regulations.
• Contribution to the continuous improvement of the Quality Management System.
• Work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups.
• Other additional duties may be assigned.

Requirements

• Bachelor's degree in a scientific discipline.
• 5+ years related pharmaceutical experience, preferably in manufacturing, quality assurance, or cGxP auditing.
• Demonstrated project management experience in leading cross-functional teams.
• ASQ Certification as a Quality Auditor, Manager, or Engineer a plus.
• Superior knowledge of U.S. cGMPs and FDA guidance.
• Experience in SAP is preferred.

Nice-to-haves

• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Effective influence management and conflict resolution abilities.
• Highly developed investigative and reporting skills.
• Effective organization and time management skills.
• Ability to travel (up to 30%).
• Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
• Flexible, able to adapt quickly to change in a fast-paced environment.
• In-depth knowledge of product standards.

Benefits

• Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision.
• 401k.
• On the job training / cross-training.
• Life Insurance, disability insurance, and voluntary life insurance for family members available.
• Accident and critical illness insurance optional.
• Scheduled performance reviews.
• Referral program.