Collins Consulting, Inc. · 1 day ago
QA Specialist III
Abbott Park, IL
Full-time
Onsite
Senior Level
$34/hr - $39/hr
5+ years expCollins Consulting, Inc. is seeking a QA Specialist III who will be primarily responsible for providing quality consultation, training, auditing, and coordination of projects to enhance the quality of new product development programs. The role involves ensuring compliance with quality standards and regulations in the pharmaceutical and medical device industries.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
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 on 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
Qualification
Required
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
Laboratory experience
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Experience Level = 5-7 Years
Preferred
Quality Assurance auditing experience
Laboratory experience
Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA)
Benefits
401(k)
Medical, Dental and Vision Insurance
Term Life Insurance
Accidental Death and Dismemberment
Long Term Disability
Company
Collins Consulting, Inc.
Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase