Katalyst CRO · 2 months ago
Quality Systems Specialist
San Mateo, CA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is a company focused on quality management in the biologics manufacturing sector, and they are seeking a Quality Systems Specialist. The role involves facilitating cross-functional meetings, managing change records, and contributing to the maintenance and improvement of quality systems processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations
Navigate complex change review discussions, facilitating decisions regarding approach and follow-up actions, and document these evaluations
Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintain associated tracking tools and databases
Assist in the management review process by developing and generating quality system metrics and trends, escalating issues as necessary
Contribute to the maintenance and improvement of quality systems processes as needed
Collaborate directly with operating entities and internal clients to ensure follow-up on change tasks
Qualification
Required
6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA, including mandatory change control experience
4+ years of relevant experience with a MS degree
Change control experience from a regulated industry such as medical device, pharma, nutraceuticals, or vitamins, with FDA-related knowledge
Strong communication skills, good time management skills, and attention to detail
Knowledge of good technical writing
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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