Bioprocess Production Specialist

1 week ago


Carlsbad, United States Argonaut Manufacturing Services Full time
About Us

Argonaut Manufacturing Services, Inc. is a leading provider of cGMP manufacturing solutions.

Salary and Benefits

We offer an estimated annual salary range of $65,000 - $90,000, depending on experience, plus comprehensive benefits including health insurance, 401(k) matching, and paid time off.

Job Description

The Bioprocess Technician II or III will be responsible for executing production processes in a cGMP, ISO 13485 environment. This individual will adhere to quality systems, regulatory guidelines, and safety protocols.

Key Responsibilities:
  • Work within a 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.
  • Formulate liquid assays, operate large equipment, create 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.
  • Monitor machinery and report 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.
  • Manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations.
  • Handle liquid nitrogen according to OSHA safety guidelines.
  • Lift heavy liquid nitrogen Dewars using proper body mechanics.
  • Load/Unload materials to automated machines and lyophilizers.
  • Perform 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.
  • 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.
  • Assist with review of quality assurance logbooks.
Requirements

This position 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.

Preferred Qualifications:
  • Punctuality and ability to maintain attendance.
  • Ability to read and follow detailed written instructions and have good verbal/written communication skills.
  • Ability to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.
  • Understanding of 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.


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