What are the responsibilities and job description for the QC Specialist/Archivist position at Resolian?
Responsibilities
JOB DESCRIPTION
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
JOB DESCRIPTION
- 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
- 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
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.