Quality Assurance (QA) Specialist III

Job Title: Quality Assurance (QA) Specialist III

Location: Lake County, IL 60064

Duration: 10 Months

Primarily responsible for carrying out tasks related to core job responsibilities by providing qualityconsultation, training, auditing and coordination of projects necessary to maintain and improve the qualityof 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 currentregulations, 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 managementprocesses

* 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 functionalareas personnel

* Assist GxP QA Management on the collaboration with the Inspection Management group onexternal audits by regulatory agencies and customers

* Develop / maintain and update departmental systems, procedures and records pertinent toposition 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 minimaloversight

* This is an experienced level compliance position that reports to the Director GxPCompliance or designee. This individual is expected to identify and resolve problems, through effectiveinterpersonal skills. The incumbent will work effectively independently, mentor complianceauditors, and also be an effective cross-functional team leader.

Qualifications and Experience.

• * Bachelor's degree preferably in life sciences or engineering
• * Demonstrated strong leadership competencies, proficient level of technical capabilities, andindependence. 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 satisfactorysubstitute 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