GMP Internal Auditor

We currently have an opportunity for a GMP Internal Auditor on a contract basis. This role will ensure compliance with the client's company policies, regulations, and global standards. The GMP Internal Auditor will collaborate cross-functionally within businesses and grow the auditing capability within Quality Assurance, utilizing expertise, knowledge, and experience of best-practice methodologies in the industry.

Responsibilities

• Ensure compliance to the client's company policies, regulations, and standards globally.
• Collaborate cross-functionally within businesses.
• Grow the auditing capability within Quality Assurance.
• Perform Quality Management System (QMS) compliance audits as a team member and/or lead as required.
• Interact with all levels of internal management across functions and business units.
• Communicate results of audits and internal control evaluations in reports and presentations.
• Evaluate audit responses for adequacy, including root cause analysis and timeliness, and facilitate appropriate corrective actions.
• Resolve complex issues and escalate concerns through business and Quality Management.
• Serve as a cGMP consultant/subject matter expert and provide researched and supported opinions on complex compliance issues.
• Participate in and/or support the preparation of regulatory agency inspections and/or responses to external observations.
• Maintain all organizational and professional ethical standards, while actively advocating and supervising compliance.
• Actively support continuous improvement of the audit program and compliance strategy.
• Participate in special projects/investigations as needed.
• Lead compliance activities such as best practice sharing, leading QA councils for manufacturing plants, and other quality improvement initiatives.
• Lead or participate in Audit Program Management and audit risk calculation strategy.
• Lead or participate in Site Risk Program management and drive improvements.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Detailed knowledge of applicable global regulations and standards.
• Minimum 10 years of experience in auditing or site quality leading experience in a drug or medical device company.
• Proven multitasking, project management, and execution skills.
• Excellent verbal and written communication skills, including presentation skills.
• Strong courage of conviction, conflict resolution, interpersonal, and influencing skills.
• Strong technical, analytical, judgment, and problem-solving skills.
• Ability to build relationships across functional boundaries at multiple levels internally and externally.
• Ability to independently make quick, sound decisions with limited data and execute appropriate judgment on when to escalate information.
• Self-motivated and able to work independently within defined timelines.
• Proven understanding of quality system software.
• Good understanding of Windows-based applications (e.g., Word, Excel, PowerPoint).

Location

• Round Lake, IL

Employment Type

• W2

Benefits

• Choice of medical, dental, and vision plans
• Paid vacation time
• Competitive base salary
• 401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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