Qc Laboratory Assistant

3 weeks ago

Hamilton, Canada Centre For Probe Development And Commercialization Full time

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

**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**
- General Lab Facility Systems and Maintenance for Quality Control (includes Analytical Development Lab)
- Responsible for laboratory housekeeping as follows:

- Maintain required QC facility documents in an audit-ready state.
- Weekly Checks of Eyewash and Shower stations.
- Waste Disposal of Non-Radioactive and Radioactive waste (with support/supervision); includes chemical, biological, glass, and household waste.
- Laboratory glassware cleaning and organization/storage.
- Daily/weekly cleaning of office and lab benches and workspaces.
- Lab Material Management
- 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.
- Equipment Systems
- Routine (daily, weekly) calibration of pH meters, balances, dose calibrators, and other equipment where applicable.
- Weekly maintenance of water baths and sonicators.
- Temperature Sensors Data Review and Trending
- Controlled Temperature Unit (CTU) maintenance; clean, defrost, etc. for refrigerators, freezers and stability chambers.
- Escort external contractors for routine maintenance and repair.
- Standards inventory maintenance, tracking, and ordering.
- Weekly equipment monitoring, check calibration labels, etc.
- Organize, clean, and store lead pots used for radioactive product storage.
- Quality Control Tasks
- 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)
- 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.
- Other laboratory QC tasks as assigned.

**Experience Necessary**
- College Diploma in Chemistry, Biotechnology, Biology or a related field; or equivalent (e.g. minimum 2 years University completed)
- Previous laboratory experience is an asset; full training will be provided.
- 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.
- 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.
- Willingness to work in quality control laboratory which works with and tests radioactive materials and requires all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- 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.
- Please note that AtomVie operates 24/7 and may require morning, day, and evening shift work including weekends.

**AtomVie offers**:

- Group Health & Dental Benefits
-

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