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Role Description
This role is primarily responsible for auditing sterilization processes to ensure compliance with regulatory standards and internal quality requirements.
- Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories.
- Perform internal audits of Medline divisions and manufacturing sites.
- Lead complex, critical, supplier regulatory projects involving cross-functional teams.
Qualifications
- Bachelor’s degree in microbiology, chemistry, engineering or related field.
- 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.
- 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).
Requirements
- Experience with USP 61/62 for Microbial Testing of Non-Steriles.
- Experience in CAPA (Corrective and Preventive Actions) management.
Benefits
- Competitive total rewards package.
- Continuing education & training.
- Tremendous potential with a growing worldwide organization.
- Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
- For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
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