Job summary
Manufacturing Technician positionResponsible for executing all processes in productionExpected to fully participate in departmental projects and quality working teams
Job seniority: mid-to-senior level
Responsibilities
• Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with our quality system.• Execute documentation based on cGMP and GDP procedures, as well as perform documentation review post manufacturing execution.• Participate in Quality Working Teams and Continuous Improvement Teams.• Responsible for formulation of liquid assays, operation of large equipment, creating lyophilized product in an ISO cleanroom environment, daily washing of regularly used tools.• Visual inspection of lyophilized product and heat seals of packaging.• Clean and sanitize manufacturing and associated support areas.• Responsible for monitoring machinery and reporting alarms to lead technician or Supervisor.• Conduct daily documentation review.• Participate in Quality Working Teams and Continuous Improvement Teams.• Operate large machinery and monitor automated.• Manually clean equipment and perform preventative maintenance.• Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations.• Handling of liquid nitrogen according to OSHA safety guidelines.• Loading/Unload materials to automated machines and lyophilizers.• Responsible for Biodecontamination and appearance of all formulation and lyophilization production areas.• Prepare liquid solutions for freezing into solid product.• Perform daily arithmetic calculations as it pertains to total volume and liquid concentrations.• Perform daily unit conversions as it pertains to gravimetric and volumetric measurements.• Operate production equipment such as pipettes, balances, pH meter and heat sealers.• Monitor department equipment for proper operation that is within calibration.• May perform safety and cGMP inspections or observations.• Ensure compliance with SOP/cGMP and cGDP requirements.• Assist in training/ leading of new team members in production activities.• Assist in updating and new revision of standard operating procedures (SOP).• Author Non-Conformance Reports (NCR) and risk analysis memos.• Receive and distribute supplies into the production area as necessary.• Perform NetSuite transaction, issue material , completion and closing of work orders.• May assist with review of quality assurance logbooks.• May perform other duties as assigned.
Requirements
• Level II: Requires a bachelor's degree in a related field and at least 1 year of work experience at Argonaut or in similar/related industry; or high school diploma with 3 years' related work experience.• Level III: Requires a bachelor's degree in a related field and at least 5+ years' of work experience at Argonaut; or high school diploma with at least 5+ years' related work experience.• Must be punctual and maintain attendance.• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.• Must be able to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.• Understands Manufacturing Production Processes as it pertains to product integrity processes; visual inspection of components, finished goods; manual and semi-automated packaging; product labeling.• Knowledge of basic chemical and biological safety procedures.• Basic Knowledge of Formulation/Lyophilization operations and capabilities.• 3 or more years' experience in Formulations or Lab Bench• 5 or more years' experience in a GMP environment• 1 or more years' experience in Contract Manufacturing• 3 or more years' experience in pH/Balance/Pipette
