Sr Quality Assurance Auditor - Chicagoland area

Job Summary Only considering candidates local to the Chicagoland area or willing to relocate at this time. JOB SUMMARY: Audit a broad, global supplier reputed company against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full reputed company of reputed company products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. reputed company internal audits of reputed company divisions and manufacturing sites. reputed company reputed company, critical, supplier regulatory projects involving cross-functional teams.

Job Description

MAJOR RESPONSIBILITIES: 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 reputed company with Quality Management System requirements. Plan, schedule and execute reputed company and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, 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 reputed company suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. Plan, schedule and execute reputed company 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 reputed company 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 reputed company 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 reputed company specifications, including novel and high-risk products and services. Assist in integration of new acquisitions into reputed company’s quality system. reputed company 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. Education - Bachelor’s degree in microbiology, chemistry, engineering or reputed company field. Work Experience - At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role reputed company 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 reputed company 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 reputed company escalation of issues is necessary. - Experience controlling and coordinating reputed company projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (reputed company state, out of state and/or internationally). PREFERRED JOB REQUIREMENTS - 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. reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. 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. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in reputed company forms, acting inclusively, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates reputed company individuals without regard to race, reputed company, religion, gender, gender identity or expression, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career reputed company a high-performing environment, this is the reputed company for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. reputed company is the largest provider of medical-surgical products and reputed company serving reputed company points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, reputed company helps reputed company providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how reputed company makes reputed company run reputed company, visit www.reputed company.com. Apply tot his job Apply To this Job