Katalyst CRO · 17 hours ago
QA Compliance Specialist
North Chicago, IL
Full-time
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on quality assurance in the pharmaceutical industry. The QA Compliance Specialist is responsible for ensuring product quality and compliance with regulations through auditing, training, and consultation, while also managing supplier relationships and internal audits.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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 one 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
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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