Onsite – Lake County, IL
Quality Assurance (QA) Specialist III
Manager's update
• Working with suppliers
• Covering a wide range of suppliers in clinical practices, R&D, and non-commercial products
• Position can be extended
• A bachelor’s degree is required
• Some travel domestically and internationally
• This is an experienced auditor
• This is a regulatory compliance perspective of an auditor
• This is higher level position
• Regulatory and Quality experience
• Auditor experience, US FDA, regulations, GLP, GMP, GCP
• Drug-related experience
• Pharma experience or knowledge is required
• A bachelor’s degree is required
• QA experience required
• Experience with regulation
• Some clinical or regulatory practice
• Assisting senior auditors, Regulatory affairs exp, pharma exp, drug-related
• Pharma knowledge, QA experience, American Society for Quality (ASQ)Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA) is a plus
• One-track experience, Track-wise experience
• Basics Microsoft platform
• Basic computer knowledge will be helpful
• Laboratory experience is preferred
• Manufacturing or analytical background
• Experience with TPM is a plus
• Any QA auditing and Bach record experience
• Pharma or medical device
• 5 plus years of experience is required
• Job Description:
• Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience
Carryout job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
• Independently plan and conduct internal system audits and external GxP supplier audits
• Maintain approved supplier list, global audit schedule and participate in supplier management processes
• Gathers internal and external audit metrics and presents to QA management for trend analysis
• Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
• Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel
• Assist GxP QA Management on the collaboration with the Inspection Management group one External audits by regulatory agencies and customers
• Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities
• Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
• Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight
• This is an experienced level compliance position that reports to the Director GxP Compliance or designee. This individual is expected to identify and resolve problems, through effective interpersonal skills.
• The incumbent will work effectively independently, mentor compliance auditors, and also be an effective cross-functional team leader.
Qualifications:
Experience.
• Bachelor’s degree preferably in life sciences or engineering
• Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies
• 5+ years’ experience in function or related fields such as: Thorough understanding of international GxP regulatory standards (e.g. GMP, GLP, GCP, GDP,
• GCLP, etc.)
• Quality Assurance / Regulatory Affairs/Pharmaceutical / Device / Healthcare Industry
• Quality Assurance auditing experience (preferred)
• Laboratory experience (preferred)
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA)
• Experience Level = 5-7 Years
