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St-coordinator, Qc Stability Richmond Hill
2 weeks ago
**About Apotex Inc.**
**Job Summary**:
Providing assistance to Stability Coordinators by ensuring that samples received for the QC Stability program are stored and scheduled for testing appropriately, which includes labelling, and removal of stability samples.
**Responsibilities**:
- Provide support in data analysis and execution of tasks related to the Stability Reduction Initiative for the QC Stability and QC Laboratory departments.
- Ensure that all samples received are logged correctly and accurately into Labware LIMS and stored in the appropriate stability chamber in a timely fashion.
- Create Labware LIMS protocols to control the testing of the stability samples and ensure that all the appropriate storage conditions and time points are included in the protocols.
- Import initial testing data and/or perform manual entry, as well as, sending samples to the QC laboratory for initial testing.
- On a weekly basis, or as required, pull samples from the stability chambers and send to the QC laboratory for testing, and as well, perform weekly folder checks.
- Maintain detailed and accurate records of all sample movement and update inventory records accordingly.
- Run monthly inventory report in Labware LIMS and perform monthly inventory checks.
- Perform monthly inventory checks on controlled substances and provide illicit values to the site QPICs.
- Run disposal report in Labware LIMS and dispose of Stability samples for completed studies.
- Place requisition orders for batches from inventory control, when required.
- Prepare samples for shipment in accordance with established Apotex procedures, regulatory, and safety procedures to internal and external customers.
- Provide weekly status updates to the Supervisor, QC Stability.
- Works as an effective team member to meet department goals, sharing knowledge with team members and across QC.
- Monitor training progress and ensure all training gaps are completed within MyHR for Documents, GMP, Safety, Technical and Software courses.
- Work as a member of a team to achieve all quality/compliance outcomes.
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
- All other relevant duties as assigned.
**Job Requirements**:
**Education**:
- Enrolled in a post-secondary recognized educational institution in Chemistry, Biology, Pharmaceutical and/or Health Sciences.
**Knowledge, Skills and Abilities**:
- Theoretical knowledge of ICH Guidelines as it pertains to Commercial Stability.
- Scientific background in laboratory analysis of solid or liquid dosage forms is recommended.
- Excellent written and verbal English communication skills.
- Ability to handle multiple work assignments and priorities in a fast-paced environment.
- Well balanced interpersonal skills.
**Experience**:
- Scientific background in laboratory analysis of solid or liquid dosage forms is recommended.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
