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Senior QA Auditor

Company: Fresenius Kabi
Location: Melrose Park
Posted on: January 27, 2023

Job Description:

Join a global healthcare leader where you work with a clear purpose and career growth opportunities. Health Benefits begin day 1 of employment: Health InsuranceDental InsuranceVision InsurancePrescription CoverageFlexible Spending Accounts We also offer the following benefits: 3 Weeks Paid Vacation, Holiday pay and paid Sick time401(k) with a company contribution that is 100% vestedTuition ReimbursementEmployee Assistance ProgramDisability InsuranceLife InsuranceDependent Spouse and Child Life InsuranceAuto and home insurance programsLegal InsuranceThe Sr Quality Assurance Auditor is responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of FK facilities and external audits of FK suppliers in accordance with FK policies and procedures. Identifies top compliance risks and communicates to FK Management.Internal Audits Lead internal audits of FK facilities based on the FDA System Based Inspection Policy and general cGMP. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk. Lead/participate in Global internal audits of Fresenius Kabi facilities as required. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings to FK and FK USA management. Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy. Lead gap assessment audits and PAI readiness inspections at FK USA facilities as needed. Prepare monthly reports of completed activities including trend analysis, if required and submit to the Sr. Manager, QA Compliance and Senior QA Management.External Audits Lead external audits of FK raw material suppliers including Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, and Contract Laboratories. Develop audit plan, conduct quality audit, prepare audit reports and communicate findings, including compliance risk. Recommends approval or disapproval of suppliers based on compliance assessment. Review and evaluate supplier's audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet FK specifications and quality requirements. Follow-up on prior audit recommendations to ensure implementation and compliance. Assist in the maintenance of the annual internal and external audit schedules as requested by management. Lead for cause audits of external suppliers as request by management.Other Activities Assist in and/or lead the development of compliance and quality training as required. Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks. Maintain audit files and databases to ensure all documentation is current and complete. Assumes additional duties and responsibilities as assigned.Requirements Bachelors degree in the Sciences (Masters preferred) with a minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical or biotech industries preferred but combination with medical device experience is acceptable. Certification as a CQA Auditor, CQE etc preferred. Minimum 4 years of experience in pharmaceutical quality audits including both external and internal auditing. At least one year of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, cGMP and GLP regulations is required. Display in-depth understanding of FDA trends, FDA and EU regulations and guidelines and ISO 9001:2008. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations. Demonstrated ability to lead teams and handle project management activities with supervision. Must be able to travel domestically and/or internationally up to 75% of the time. Demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments. Effective communication skills and technical writing ability.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.Job Type: Full-timePay: $75,000.00 - $85,000.00 per year

Keywords: Fresenius Kabi, Chicago , Senior QA Auditor, Accounting, Auditing , Melrose Park, Illinois

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