Katalyst CRO · 2 months ago
Qualification Specialist � Equipment Integration
New York, NY
Contract
Onsite
Mid LevelKatalyst CRO is seeking a Qualification Specialist in the Equipment Integration team to ensure compliance with GMP requirements. The role involves transferring lab equipment to the Roche Connect Network and developing strategies for qualification of digital solutions while maintaining regulatory compliance.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and implement qualification strategies for digital equipment, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards
Create qualification plans and protocols for equipment connected to RCN, including interfaces and automation applications. Ensure all qualification activities are properly documented and executed according to established procedures
Conduct risk assessments to identify potential risks associated with digital solutions in a GMP environment. Develop risk mitigation strategies and ensure appropriate controls are in place
Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. Execute test cases, analyze results, and document findings
Ensure all qualification activities comply with relevant regulatory requirements such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation
Drive continuous improvement initiatives related to qualification processes, tools, and methodologies. Stay updated with industry trends and regulatory requirements in validation
Act as an interface between business and IT teams, serving as a key contact point for business leads to launch initiatives, lead, and drive the scoping phase
Qualification
Required
Strong understanding of lab systems lifecycle models and experience with business/end-user applications
In-depth knowledge of qualification principles and practices in a GMP environment
Hands-on experience in qualification of digital solutions, including release management processes and controls
Proven experience in managing infrastructure across multiple product releases with a passion for reliability and compliance
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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