Senior Auditor; Sterilization

Overview

Position requires travel of up to 50% of the time for business purposes (within state, out of state and/or internationally)

Although Remote, the selected individual will be required to visit the office regularly (
Chicagoland
area
).

This role is primarily responsible for auditing sterilization processes to ensure compliance with regulatory standards and internal quality requirements

• Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals.
• As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements.
• Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations,
  ISO
  13485
  , MDSAP
  , MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers.
• Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers.
• Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements.
  
  - Conduct adequate CAPA follow-up for supplier and internal audits.
• Write audit reports and communicate results to upper management.
• Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally.
• Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies.
• Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers.
• Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs.
• Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services.
• Assist in integration of new acquisitions into Medline’s quality system. Perform due diligence audits for potential acquisitions.
• Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers. Assist in managing the rotational QA program.

- Bachelor’s degree in microbiology, chemistry, engineering or related field.

Key requirements in a nutshell:

• One or a combination of radiation (gamma/e-beam), EO (Ethylene Oxide), or Steam.
• Test method validations (bioburden and sterility).

- At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing.

- Experience with
FDA regulations (21 CFR 820, 21 CFR 210/211).

- Experience with
ISO 13485
.

- Experience applying knowledge of process validation, method validation and sterilization processes. Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills.

- Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.

- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.

- Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.

- Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

- Experience with USP 61/62 for Microbial Testing of Non-Steriles.

- Experience applying knowledge of process validation, method validation and sterilization processes.

- Experience in CAPA (Corrective and Preventive Actions) management.