Overview
QA IT Lead -SME Jobs in New York, New York, USA at Katalyst CRO
Location: New York
Join to apply for the
QA IT Lead – SME
role at
Katalyst CRO
3 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Responsibilities
Ensure IT processes and procedures meet Quality System requirements.
Participate and support the Quality Risk Management (QRM) principles in risk assessment initiatives.
Support the development, review, and approval of Quality Assurance Agreements (QAA) and the Approved Supplier List (ASL) process.
Collaborate with other functional areas to gather information and provide guidance throughout the quality management system and improvement projects.
Ensure new systems/processes/procedures comply with SOPs, WIs, data, and regulatory guidelines for IT and Software validation.
Assist in resolving inspection management concerns related to software applications, procedures, and data integrity.
Requirements
Bachelor’s degree in Life Science, Computer Science, Engineering, or IT preferred.
At least 7 years in Pharma manufacturing, with experience in Data Integrity, Deviations, GXP, IT QA Systems, hardware servers, CAPA, SOPs, training, audits, and FDA pre-CSV validation.
This role is not for testers or validation specialists.
Support investigations, risk assessments, and IT operations, verifying GxP computerized systems post-validation.
Over 7 years of experience in IT, Computer Science, Engineering, or Chemistry within FDA-regulated environments.
Thorough knowledge of IT CSV, GxP compliance, FDA CFRs, Eudralex, Data Integrity, SDLC validation, and software quality requirements.
Experience with root cause analysis, risk management, change control, incident, and deviation management.
Strong project management skills, especially in systems validation across various areas such as laboratory, utilities, manufacturing, or information systems.
Additional Details
Seniority level:
Mid-Senior level
Employment type:
Contract
Job function:
Quality Assurance
Industry: Pharmaceutical Manufacturing
Referrals can increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new Quality Assurance Lead jobs in Rensselaer, NY.
#J-18808-Ljbffr
Title: QA IT Lead -SME
Company: Katalyst CRO
Location: New York, New York, USA
Category: IT/Tech (Data Analyst, Data Scientist), Quality Assurance – QA/QC (Data Analyst)
