We're looking for a Senior Quality Assurance Auditor, working in the Biotechnology/Medical Devices industry in Melrose Park, Illinois, United States.
Schedules and leads domestic and international Corporate and Regional Compliance Audits, including internal audits of facilities and external audits of suppliers in accordance with policies and procedures.
Identifies top compliance risks and communicates to Management.
Leads internal audits of facilities based on the FDA System Based Inspection Policy and general cGMP.
Develops audit plans, conducts quality audits, prepares audit reports and communicates findings, including compliance risk.
Leads external audits of raw material suppliers including Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, and Contract Laboratories.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelors degree in 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
3-5 years of experience in pharmaceutical quality audits including both external and internal auditing
1 year of FDA system-based inspection is required
In-depth knowledge of Aseptic Processing, cGMP and GLP regulations is required
Certification as a CQA Auditor, CQE etc. preferred
In-depth understanding of FDA trends, FDA and EU regulations, and guidelines and ISO 9001:2008
Ability to travel domestically and/or internationally up to 75% of the time
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.