Altasciences
Pharmaceutical
QCReviewer,LBA
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QC Reviewer, LBA at Altasciences. Skills: Quality control, Data review, GLP regulations. Perform quality control for data generated. Ensure batch related documentation is completed accurately”
Industry & Context.
What They're Looking For.
Must Have
College degree or University degree in Chemistry, Biochemistry or Immunology or equivalent field, 3 years of experience in data review and quality control, Understand general SOPs, Knowledge of GLP regulations, Good organizational skills, Attentive to details, Good communication (written and verbal in French & English)
Nice to Have
Pertinent experience may be considered in lieu of degree
What You'll Do.
Perform quality control for data generated
Ensure batch related documentation is completed accurately
Ensure procedures are respected as per company SOPs
Draft study documents
Perform quality control batch review
Perform multi-batch trend analysis
Compile study documentation
Provide report and/or final results within study timelines
exception or events are reflected
Assure analysis conducted are reported and accurate
Responsible for daily in process quality control
Raise quality issues or trends to line manager
Support responses to QA reports
Monitor quality within laboratory according to GLP
Support and mentor analysts in documentation procedures
Participate in basic training of laboratory staff
Ensure verification of laboratory instruments
Ensure harmonization of techniques
process and documentation
Participate in laboratory inspections
Execute and report deviations
Report health and safety concerns
Assist for planning sample analysis
Maintain timeline and scheduling commitments
Stay up to date on new SOPs
Observe company guidelines and policies
Respect Health and Safety standards
How You'll Work.
Team & Collaboration
Work with different teams
Communication Scope
Written communication; Verbal communication
Full Job Description
**Your New Company!** At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. **About The Role** The QC reviewer, LBA is responsible to perform the quality control for data generated and work conducted in the laboratory. **What You 'll Do Here** * Ensures that all batch related documentation is completed accurately and in a timely manner by the analysts and that all procedures are respected as per the company’s SOPs. * Based on training QC reviewer can draft study documents for BPI review such as Memo to File, SOP/Protocol/Study Plan deviations., perform quality control batch review by performing multi-batch trend analysis and compile study documentation, * Based on training, provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate for the review of the Bioanalytical Principal Investigator . * Based on training, responsible for daily in process quality control for batches ongoing in the lab. * Raises any flags to line manager regarding any quality issue or trends observed and is part of addressing these issues in an appropriate manner. * Supports responses to QA reports. * Monitors the quality within the laboratory acco
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