QC Laboratory Assistant

at  AtomVie Global Radiopharma Inc

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

REQUIREMENTS

• College Diploma in Chemistry, Biotechnology, Biology or a related field; or equivalent.
• Previous laboratory experience is an asset.
• Experience in a pharmaceutical cGMP environment, experience in aseptic operations (use of a BSC - Biological Safety Cabinet) and working under Canadian Nuclear Safety Commission regulations are assets in this role.
• Please note that AtomVie operates 24/7 and may require morning, day, and evening shift work including weekends.

ABOUT THE ROLE

The QC Laboratory Assistant is responsible for routine laboratory housekeeping and maintenance, supporting the laboratory team to maintain a clean, organized and GMP-compliant radiopharmaceutical quality control facility. You will also be performing simple sample preparations and tests, data entry, and documentation support tasks.
This position requires fixed evening, night or early morning shifts and work over weekends, e.g. Thursday to Monday.

WHAT YOU WILL DO

• Responsible for laboratory housekeeping including maintenance of required QC facility documents in an audit-ready state, conducting weekly Checks of Eyewash and Shower stations.
• Responsible for waste Disposal of Non-Radioactive and Radioactive waste (with support/supervision); includes chemical, biological, glass, and household waste.
• Ensure Laboratory glassware cleaning and organization/storage including daily/weekly cleaning of office and lab benches and workspaces.
• Order, receive and login shipments and maintain the inventories (e.g., materials including reagents, columns, and other consumable supplies).
• Identify and discard expired materials according to proper chemical waste handling procedures.
• Perform routine (daily, weekly) calibration of pH meters, balances, dose calibrators, and other equipment where applicable.
• Ensure weekly maintenance of water baths and sonicators.
• Ensure temperature Sensors Data Review and Trending
• Perform controlled Temperature Unit (CTU) maintenance; clean, defrost, etc. for refrigerators, freezers and stability chambers.
• Maintain, track, and order Standards inventory.
• Perform weekly equipment monitoring, check calibration labels, etc.
• Prepare documentation for Raw Material Sampling and External Laboratory Testing, and coordinate shipping to contract laboratories.
• Prepare solutions used for QC testing (eg., mobile phases and other solutions as required)
• Support QC by performing fundamental lab tests (e.g., pH Bacterial Endotoxin) within defined timeframes.
• Participate in technical review (peer data review) of test reports for trained tasks (eg., pH. Bacterial Endotoxin, balance calibrations, and more)
• Conduct routine data entry, data trending, or evaluation/assessment to support QC.
• Scan documents and file/archive as instructed.
• Conduct all work in accordance with company Standard Operating Procedures (SOPs) or Standard Test Methods (STMs) and raise any deviations immediately to the attention of Lab Management.
• Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance.
• Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
• Perform other laboratory QC tasks as assigned.

WHAT YOU BRING TO THE ROLE

• Willingness to work in quality control laboratory which works with and tests radioactive materials
• Manual dexterity to perform intricate and/or repetitive tasks.
• Ability to lift and move heavy weights up to 10 kilograms is required.
• Ability to wear all work-related personal protective equipment (PPE) such as gloves, sleeve covers, lab coat masks, goggles, respirators, and safety shoes as required.
• Proficiency with spreadsheets (e.g. Excel, Google Sheets), word processing software (e.g. Word) and ability to generate technical data summaries, assessments and reports.
• Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.