Education & Qualifications:
- BSc in one of life sciences (ie. Biochemistry, Chemistry, Cell biology) or equivalent degree
- Working knowledge of GMP environment an asset
- Intermediate skill level in Microsoft Office applications (for example, Word, Excel, Powerpoint, Sharepoint, Visio, Access and Project)
- Knowledgeable on quality systems such as ISO 13485. cGMP experience a definite asset
- Excellent verbal and written communication skills
- Ability to balance speed and accuracy requirements
- Ability to lift 25 to 30lbs in cold room environment
- Ability to work in a fast paced environment. Exposure to Lean Principles a definite asset
Duties & Responsibilities:
- Aseptic manufacturing in a clean-room environment, understanding of compliance regulatory standards for ISO 05/07/08 classification
- Safely use standard production equipment including, but not limited to, personal safety equipment, balances, volumetric glassware, pumps, filters, general production equipment, test equipment, and pipettes
- Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation (when required)
- Follow Standard Operating Procedures, Safety Policies, and current Good Manufacturing Practices to ensure compliance is met
- Performs routine processes related to bulk formulation and aseptic filling (ex. aseptic processing, not limited to aseptic filtration, aseptic fill, preparation of ISO 5 environment)
- This includes but is not limited to: working inside Cleanroom suite for several hours at a time, weighing, measuring and checking raw materials to ensure batches manufactured contain proper ingredients and quantities, cleaning equipment located in ISO 5 as per approved procedures, performing repetitive tasks while gowned (hood, mask, coveralls, shoe covers, gloves, etc), may assist with validation activities by executing applicable protocols.
- Shift work will be required. needed
- Occasional weekend work (Saturday and/ Sunday) may be required