QC Specialist/Archivist
About The Position
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
Requirements
- 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
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
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What This Job Offers
Career Level
Entry Level
Number of Employees
251-500 employees
