Manager, Quality Assurance Auditor

Responsibilities

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

• Must have at least 5+ years of extensive experience in pharmaceutical and / or biotechnology quality audits including both external and internal auditing. At least five (5) years of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, GMP and other GxP regulations.
• Requires a display of in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard. Must be able to demonstra

Benefits

Additional Information

Job Summary The Manager, Quality Assurance Auditor is responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of Fresenius Kabi facilities and external audits of Fresenius Kabi suppliers in accordance with Fresenius Kabi policies and procedures. Identifies top compliance risks and communicates to Fresenius Kabi Management. Must be able to function independently with limited supervision Processes complaints to ensure timely and accurate evaluation and completion of customer complaints. May back up the US Vigilance Team with submissions of Field Alert Reports (FAR) and Medical Device Reports (MDR) as required to comply with all regulatory obligations. Create reports used for Key Process Indicators (KPI) and aids in the processing of complaints. Salary Range: Job Posting Range: $125K - $135,600 - Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) - Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. - Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role: Onsite 3 days per week Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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