Fusion Life Sciences Technologies LLC · 9 hours ago
Pharma Quality Risk Management
North Chicago, IL
Contract
Onsite
Senior Level
5+ years expFusion Life Sciences Technologies LLC is focused on improving the quality of new product development programs in the pharmaceutical industry. The QA Specialist is responsible for providing quality consultation, conducting audits, and ensuring compliance with regulations and guidelines for manufactured products and processes.
Data ManagementLife SciencePharmaceuticalStaffing Agency
Hiring Manager
Vijaya Bandi
Responsibilities
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)
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 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
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC 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 (57)
2024 (95)
2023 (116)
2022 (135)
2021 (128)
2020 (133)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Executive Partner
Company data provided by crunchbase