Coordinator, QC

Job Summary

• Responsible for keeping accurate inventory of all resources used in  QC lab for testing .
• Provides support to the department by assisting chemists with resources required in their work.
• Responsible for labelling, storing and disposing of samples received in the QC lab.

Job Responsibilities

• Log and/or receive samples in LIMS for Raw materials, In-Process, Semi-Finished, Stability and STR samples.
• Monitor and maintain inventory for Primary and Secondary Standards, including Controlled substances ensuring the availability for use.
• Monitor and maintain QC inventories of placebos, capsule shells, System suit tubes, Internal standards and Related compound/ impurities.
• Provide standards, placebo and Certificate of Analysis, as required for Internal and External customers.
• Dispose and removes raw material, dosage samples and expired chemicals routinely in a safe and compliant manner.
• Work in collobration with method optimaztion group to ensure standards, columns, system suitability tubes and other items  are logged in to LIMS and stored in the correct location.
• Prepare and send samples required for external testing in a timely manner.
• Maintains the inventory for the controlled substances, ensuring the samples are logged and stock reports are updated in a timely manner.
• Perform cycle count on the control substance inventory as outlined by the site QPIC. Ensure that all LIMS approved controlled substance material in the lab are disposed of in a timely manner as per established procedure
• Prepare training rosters in SAP and document the trainings in SAP  in a timely manner as required.
• Maintain confidentiality of information.
• Prepare purchase requisition/purchase order in Ariba and liaise with vendors for items purchased.
• Coordinate ancillary activities for QC such as SOP and GMP training and act as IS Business Lead for QC.
• Prioritize the LTS/IS work to be completed for the department/business unit.
• Work as an effective team member to meet departmental goals. Sharing knowledge and providing support to team members and across QC.
• Coordinates with external testing laboratories on API, Semi-finished, Finished, Stability and excipient testing as needed.
• Assists in Commercial Stability program activities such as pull samples from the chamber, labelling of samples, disposal of Stability Samples for completed studies, run inventory report, perform inventory checks, lot/project/protocol creation and other relevant duties as assigned.
• Work as an effective team member to meet departmental goals. Sharing knowledge with team members and across QC.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Ensure that all work is performed in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, all regulatory requirements, and safety standards.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Community College education in a recognized educational institution in Chemistry or a related field; with 3 years of relevant experience.
• Experience with computer software packages such as Word, Excel, Power point, LIMS and SAP
• Knowledge of Labware LIMS will be an asset
• Demonstrated accuracy and attention to details.
• Demonstrated ability to multi task and prioritize work.
• Ability to work independently or as part of a team.
• Excellent interpersonal skills.
• Excellent organizational skills.
• Excellent ability to communicate in English, both verbally and in written form.