Responsibilities

· Learn and review documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11

· Verify lab tasks are performed in accordance with Good Documentation Practices (GDP)

· Review laboratory documents and notebooks (e.g., plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations

· Learn to identify non-compliance and deviations

· Review sample analysis documents for compliance to validated/qualified methods

· Verify run pass/fail

· Follow applicable SOPs and procedural documents

· Review data result files, validation data files, and reports

· Learn to prepare and submit study data to archives

· Escalate data integrity and non-compliance issues to Management

· Enforce lab safety SOPs and requirements

· Review system audit trails

· Assemble, catalogue, preserve, and manage site-wide material, including study data and equipment records

· Retrieve requested information as required

· Maintain chain of custody and inventory of archived material

· Verify items submitted and returned are properly captured on documents for traceability

· Ensure Archives is clean and inspection ready at all times

· Record tasks in accordance to Good Documentation Practices (GDP)

· Monitor Archives environmental conditions for proper preservation of material

· Assist with client and regulatory audits as applicable

· Train others on archiving process and procedures

Skills, Education & Qualifications

· BA/BS or higher; all experiences will be evaluated

· Able to work in a regulated environment

· Able to learn regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP

· Able to review detailed data and documents

· Able to work effectively and contribute within a team

· Able to work with computer systems

· Able to document and communicate clearly

Able to perform archiving tasks

Learn more about this Employer on their Career Site

QC Specialist/Archivist