Job summary
Job post source
This job is directly from Katalyst CRO
Job overview
The QA with CSV Oversight Consultant role at Katalyst CRO involves providing quality assurance oversight for computer systems validation activities, particularly supporting the LabVantage 8.7 enhancement project and other digital initiatives.
Responsibilities and impact
The consultant will review and approve validation documentation such as Installation Qualification, Performance Qualification, and validation summary reports, ensure adherence to best practices and internal policies, and provide quality oversight rather than authoring documents.
Compensation and benefits
The job is a contract position with a salary range of approximately $75,000 to $95,000, with no additional benefits explicitly mentioned.
Experience and skills
Candidates should have prior experience authoring validation documents and knowledge of standards like GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5; experience with LabVantage 8.7 or similar LIMS/QC systems is preferred.
Company information
Katalyst CRO is a company involved in pharmaceutical manufacturing quality assurance and digital project support.
Job location and travel
The position is located in Boston, MA, and is a contract role.
Unique job features
The role focuses on quality oversight of computer systems validation rather than document creation, emphasizing compliance with regulatory standards and internal SOPs.
Company overview
Katalyst CRO is a contract research organization specializing in providing comprehensive clinical trial management and support services to pharmaceutical, biotechnology, and medical device companies. They generate revenue by offering tailored solutions in clinical operations, regulatory affairs, data management, and biostatistics to accelerate drug and device development processes. Founded with a focus on innovation and efficiency, Katalyst CRO emphasizes collaboration and cutting-edge technology to deliver high-quality results. Their expertise spans multiple therapeutic areas, making them a trusted partner in advancing healthcare solutions globally.
How to land this job
Tailor your resume to emphasize experience in Quality Assurance specifically related to Computer Systems Validation (CSV) and oversight roles, highlighting familiarity with validation documentation review and approval processes.
Focus on showcasing knowledge of regulatory standards such as GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5, as these are critical for ensuring compliance in computerized systems and data integrity.
Apply through multiple channels including Katalyst CRO’s official corporate website and LinkedIn job listings to maximize your application visibility for the QA with CSV Oversight Consultant role.
Connect with current employees or team members in the Quality Assurance or Digital Projects division at Katalyst CRO on LinkedIn; use ice breakers like commenting on recent digital initiatives or asking about their experience with LabVantage or other LIMS platforms to start a conversation.
Optimize your resume for Applicant Tracking Systems (ATS) by incorporating keywords from the job description such as 'CSV oversight,' 'validation documentation,' 'IQ,' 'PQ,' and 'GxP compliance' to improve the chances of passing initial automated screenings.
Leverage Jennie Johnson’s Power Apply feature to automate tailored resume customization, identify multiple application portals, and find relevant LinkedIn contacts, allowing you to focus your energy on networking and interview preparation.
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