Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.
We’d love to hear how you could contribute to the team!
**Please note this opportunity is for a 6 month contract**
Responsible to prepare kits while following GMP requirements. Responsible for preparing microbiological media, VHP sterilization of EM supplies for sterile lines and water sampling. Responsible for keeping accurate inventory of all resources in the Central Laboratory Services (CLS) Storage area. Provides support to the department by performing activities, which will assist Chemists and Microbiologists in their work.
* Prepare testing kits for the lab chemists.
* Monitor and maintain CLO Primary and Secondary Standards, including Controlled and Targeted substances.
* Monitor QLS inventories of placebo, capsule shells, System suit tubes, Internal standards and impurities and recommend reordering of supplies to L2 Chemist/Supervisor.
* Provide standards with C of As, as required for Internal and External customers.
* Log in raw materials for House Standardization into LIMS.
* Under direct supervision, operates pH and Conductivity Meter, and TOC analyser and applies wet chemistry techniques to analyse water, according to established In-House and Compendia regulatory requirements.
* Prepare Microbiological Media according to SOP.
* Prepare Environmental Monitoring (EM) supplies for Sterile Lines.
* VHP sanitize EM supplies for Sterile Lines.
* Collect Water (WFI, PW, pure steam, generation) samples for both Microbiological and Chemical testing.
Shared between Chemistry & Microbiology
* Perform audits of Controlled and Targeted Substances Logbook.
* Performs routine tasks such as discarding of raw material samples and dosage samples in a safe and compliant manner. Reviewing of lab chemical inventory for accuracy and to remove expired chemicals/media etc.
* Log and/or receive in LIMS Raw Material, Semi-Finished, Stability and STR samples.
* Coordinate required external testing.
* Perform Time Administration for CLO.
* Maintain Confidentiality of information.
* Perform TDA related duties.
* Perform SAP requisitioning, and place laboratory purchase orders.
* Act as IS Business Lead for CLO.
* Monitor IS performance in meeting CLO expectations.
* Prioritize the IS work to be completed for the department/business unit.
* Maintain photocopier supplies.
* Work as an effective team member to meet departmental goals. Sharing knowledge with team members and across CLO.
* Maintains compliance to all Health and Safety Standards, Good Manufacturing Practices, Good Laboratory Practices, and regulatory requirements.
* Performs additional related duties as assigned.
* Reviews, tests and approves LIMS tasks associated with document review of water analysis.
* Recognises OOS or out of trend results and under the direction of the Supervisor assists in the completion of lab investigations.
* Compiles all data obtained from testing and observations and completes report summaries.
* Performs calibration of laboratory equipment according to the department’s established calibration program.
* Act as a back up to Microbiology CLS Coordinator (if in Chemistry).
* Act as a back up to Chemistry CLS Coordinator (if in Microbiology).
* Community College education in a recognized educational institution in Chemistry, Microbiology or a related field;
* Chemistry or Microbiology Lab Experience preferred.
* Good oral and written English communication skills.
* Knowledge of GMP/GLP.
* Problem solving abilities.
* Proven organization and time management skills.
* Knowledge of Excel, Word, and other Microsoft Office Programs.
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.