Manufacturing Associate

Rate: $22-24/h

Location: Aurora

Hours: 40h/week

Type: Full-time; Contract 12-13 months

Shifts: TBD

JOB DESCRIPTION:

The Manufacturing Associate is responsible for supporting manufacturing and general operations at Prollenium Medical Technologies Inc. and reports to the Manufacturing Supervisor.

MAJOR RESPONSIBILITIES:

• Adhere to GMP and ISO13485 quality systems
• Perform line clearance and manufacturing clean-up operations in Clean Room
• Participate in the Installation, operation and qualification of manufacturing equipment including filling lines, mixing and sterilization of equipment
• Participatein process validation activities, problem solving, quality improvement drives and process improvement projects
• Perform production process operation such as, but not limited to,formulation, milling, dialyzing, degassing, filling , sterilizing of manufacturing products as per master batch instructions
• Perform equipment calibration, corrective and preventive maintenance, documentation and maintenance of files
• Writing SOPs and manufacturing documentation
• Inventory management including: ordering; stock control; order tracking and labeling
• Communicating with suppliers for material concerns and machine issues and perform troubleshooting when necessary
• Co-ordination of manufacturing set-up project with other departments including QC, QA and R&D

ADDITIONAL RESPONSIBILITIES:

• Other duties as assigned
• Participation in weekly operations meetings

MINIMUM QUALIFICATIONS:

Technical Knowledge/Experience

• Three-year college diploma in a scientific field and 1-year work
• experience in a GMP/GLP or ISO compliant environment in either
• Manufacturing, QC, QA, R&D or other technical function
• Excellent written and oral communication skills.
• Experience working in Clean Room environment

Behavioral

• Demonstrated ability to apply the following behavioral competencies on the job: Teamwork: Working effectively and productively with others
• Written Communication: Writing clearly, succinctly and understandably
• Organization and Planning: Utilizing logical, systematic and orderlyprocedures to meet objectives
• Flexibility: Agility to adapt to change

WORKING CONDITIONS:

• Requirement to work in clean room areas and laboratory setting up to 90% of the time

PREFERRED QUALIFICATIONS:

• Experience with IQ/OQ/PQ of manufacturing and/or laboratory equipment
• Experience with calibration systems set up and performing equipment calibrations
• Inventory management systems: Set up and/or management
• SOP writing experience

-AF