Katalyst CRO
Data Integrity SME (Quality Assurance)
Katalyst CRO, San Francisco, California, United States, 94199
Data Integrity SME (Quality Assurance)
We are seeking a highly skilled Data Integrity SME with a strong Quality Assurance background and hands‑on experience in analytical equipment documentation within the pharmaceutical industry. The ideal candidate will ensure data integrity compliance across analytical systems and support ongoing QA activities related to laboratory instrumentation. This role requires a deep understanding of analytical equipment data ranges, data integrity principles, and regulatory expectations for GMP environments. Candidates must be able to start within 2 weeks.
Roles & Responsibilities
Serve as the subject‑matter expert for data integrity across analytical laboratory systems.
Review, assess, and verify the data ranges, electronic records, and audit trail functionality of analytical instruments.
Lead data‑integrity gap assessments and remediation activities for QC analytical equipment.
Ensure compliance with FDA, GMP, ALCOA+, and pharmaceutical industry standards.
Collaborate with QC, QA, and IT teams to ensure proper documentation, system configuration, and control of analytical lab equipment.
Review and author technical documentation, including SOPs, validation reports, protocols, and equipment lifecycle documents.
Support investigations, CAPAs, and change controls related to analytical systems.
Provide QA oversight for analytical instrument qualification, calibration, and system updates.
Train laboratory users on data‑integrity requirements and best practices.
Education & Experience
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline.
510+ years of experience in Quality Assurance within a GMP‑regulated pharmaceutical or biotech environment.
Strong hands‑on background with analytical laboratory equipment (HPLC, UPLC, GC, UV, IR, Dissolution, etc.).
Proven expertise in data‑integrity principles, protocols, assessments, and remediation.
Experience reviewing analytical instrument data, metadata, audit trails, and system configurations.
Strong understanding of 21 CFR Part 11, Annex 11, ALCOA+ principles, and GxP documentation practices.
Excellent communication and documentation skills.
Ability to start within 2 weeks of offer.
Experience in QC/QA oversight of computerized systems.
Background in laboratory informatics systems (e.g., Empower, LabSolutions, Chromeleon, LIMS).
Prior experience working in top‑tier pharmaceutical environments.
Job Details
Seniority level: Entry level
Employment type: Contract
Job function: Information Technology
Industry: Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
San Francisco, CA $90,000.00‑$157,500.00 3 days ago
#J-18808-Ljbffr
Roles & Responsibilities
Serve as the subject‑matter expert for data integrity across analytical laboratory systems.
Review, assess, and verify the data ranges, electronic records, and audit trail functionality of analytical instruments.
Lead data‑integrity gap assessments and remediation activities for QC analytical equipment.
Ensure compliance with FDA, GMP, ALCOA+, and pharmaceutical industry standards.
Collaborate with QC, QA, and IT teams to ensure proper documentation, system configuration, and control of analytical lab equipment.
Review and author technical documentation, including SOPs, validation reports, protocols, and equipment lifecycle documents.
Support investigations, CAPAs, and change controls related to analytical systems.
Provide QA oversight for analytical instrument qualification, calibration, and system updates.
Train laboratory users on data‑integrity requirements and best practices.
Education & Experience
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline.
510+ years of experience in Quality Assurance within a GMP‑regulated pharmaceutical or biotech environment.
Strong hands‑on background with analytical laboratory equipment (HPLC, UPLC, GC, UV, IR, Dissolution, etc.).
Proven expertise in data‑integrity principles, protocols, assessments, and remediation.
Experience reviewing analytical instrument data, metadata, audit trails, and system configurations.
Strong understanding of 21 CFR Part 11, Annex 11, ALCOA+ principles, and GxP documentation practices.
Excellent communication and documentation skills.
Ability to start within 2 weeks of offer.
Experience in QC/QA oversight of computerized systems.
Background in laboratory informatics systems (e.g., Empower, LabSolutions, Chromeleon, LIMS).
Prior experience working in top‑tier pharmaceutical environments.
Job Details
Seniority level: Entry level
Employment type: Contract
Job function: Information Technology
Industry: Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
San Francisco, CA $90,000.00‑$157,500.00 3 days ago
#J-18808-Ljbffr