Scalence L.L.C. · 1 day ago
Quality Assurance (QA) Specialist III
Lake County, IL
Full-time
Onsite
Senior Level
$38/hr - $40/hr
5+ years expScalence L.L.C. is a company focused on maintaining and improving the quality of new product development programs worldwide. They are seeking a Quality Assurance (QA) Specialist III responsible for quality consultation, training, auditing, and project coordination to assure the quality of manufactured products and processes.
Information Technology & Services
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
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
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)
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase