CanniMed Therapeutics Inc., a leader in plant-based technologies, is seeking a self-driven individual to join the Quality Control team. The Quality Control/Analytical Services Manager is responsible for overseeing all the testing involved in controlled substances as well as the internal QC lab management and controls to fall within the scope of GMP on a timely basis. All QC personnel report to this individual, either directly, or indirectly.
- Manage the QC laboratory, and all analytical testing within the scope of GMP which includes proper documentation and sample tracking practices, testing expectations, and specification design.
- Oversee the QC Associates at all Aurora sites. Ensuring consistent practices of material and product release.
- Responsible for overseeing and approving all QC method development.
- Oversee QC SOP development and maintenance (keeping current with approved analytical techniques and trends)
- Enter into agreements with external contract labs and reviewing their results.
- Create and maintain training program for QC staff. Train QC personnel and ensure they are following proper QC/QA procedures.
- Ensure lab equipment is maintained in proper running order, usually via a program of scheduled maintenance.
- Assist and approve all OOS/OOT investigations.
- Participate in Quality Management team meetings. Ensure QC representation at cross functional meetings for projects etc.
- Approve QC protocols as required including those related to analytical validation.
- Formulate validation plans.
- Submit budget projections as required.
- Approve invoices for external lab activities.
- Competent understanding and functioning of HPLC, UPLC, GC, and ICP methodologies.
- Manage DMF updates and QOS Clinical Trail Applications as applicable
- A post-graduate degree in Organic or Analytical Chemistry preferred with 5 - 8 or more years of experience.
- Experience in a GMP environment is preferred.
- This position requires an A/QPIC qualification to facilitate cannabis transfers and QC activities.
- The employee must be able to manage small work groups and have the ability to generate technical reports.
- Knowledge of Microsoft EXCEL and Word are essential. Statistical analysis is required.
- Knowledge of the following regulations, guidelines, and techniques are preferred: ICH guidelines for QC, CDSA, NCR, ACMPR, Cannabis Regulation UPLC-UV and Water Activity.
We would like to thank all applicants for their interest but only those selected for an interview will be contacted.
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