Mindlance · 1 day ago
Quality Assurance (QA) Specialist III
North Chicago, IL
Full-time
Onsite
Senior Level
5+ years expMindlance is a company focused on quality assurance and regulatory compliance. They are seeking a Quality Assurance (QA) Specialist III who will be responsible for ensuring the quality of manufactured products and processes while conducting audits and providing guidance on GxP regulations.
Human Resources
Responsibilities
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 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
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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