Katalyst CRO · 9 hours ago
Senior Quality Specialist
Ridgefield, NJ
Contract
Onsite
Mid, Senior Level
2+ years expKatalyst CRO is seeking a Senior Quality Specialist to join their Quality Assurance Department at the Ridgefield site. This role involves managing supplier-related quality processes and ensuring compliance with GMP and regulatory requirements while building strong relationships with suppliers.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Manage the site's Third-Party Change Notification (TPCN) process, including logging, triaging, assignment, and determination of change criticality
Track TPCN activities to completion and prepare presentations for monthly review meetings
Review and approve third-party investigation reports related to supplier complaints and Supplier Corrective Action Reports (SCARs)
Maintain and support the Supplier Qualification Program for both new and existing suppliers/vendors
Build and maintain strong professional relationships with suppliers to ensure adherence to quality standards and drive continuous improvement
Support updates to Standard Operating Procedures (SOPs) and act as backup for other Quality Supplier Management activities as needed
Perform quality trending, metrics generation, and reporting to ensure compliance and demonstrate effective control of quality systems
Collaborate with Manufacturing Operations, QA Management, Procurement, suppliers, and service providers to resolve compliance-related issues and proactively identify GMP risk areas
Author, review, and approve GMP documentation and support training activities related to supplier management
Assist in authoring, revising, and maintaining Quality Technical Agreements (QTAs) with vendors and service providers, working closely with Procurement and Legal teams
Support and/or lead quality projects and initiatives, leveraging prior experience in project management and continuous improvement
Qualification
Required
Bachelor's degree in a science-related discipline
Minimum of 2 years of pharmaceutical industry experience
Strong experience in Supplier Management and supplier quality systems
Solid understanding of FDA regulations (21 CFR Parts 11, 210, 211, and 820) and ISO standards (ISO 13485, ISO 9001)
Strong knowledge of quality and compliance within a regulated GxP/QMS environment
Experience handling ASL, QTAs, and working with QMS systems (Athena preferred)
Excellent written, verbal communication, and organizational skills
Ability to multitask, adapt to change, and work effectively both independently and within a team
Strong problem-solving skills with the ability to research and apply past experience to drive successful outcomes
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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