cGMP Biopharma Manufacturing Technician

Argonaut Manufacturing Services Inc.

Carlsbad (CA)

On-site

USD 29,000 - 37,000

Full time

14 days+

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Job summary

Argonaut Manufacturing Services, Inc. in Carlsbad, CA, seeks a Manufacturing Technician II/III to perform on-site production tasks under cGMP and safety guidelines. You will work under the lead technician and supervisor, follow established procedures, and participate in quality and improvement teams.

This 100% on-site role is Monday–Friday, 8 hours/day with potential overtime. Start times are 6:00 AM or 12:00 PM, with a consistent schedule.

Qualifications

Punctuality and reliable attendance required.
Ability to read and follow detailed written instructions; strong verbal and written communication skills.
Proficient in reading, writing, and conversing in English to understand cGMP manufacturing processes and SOPs.
Knowledge of manufacturing production processes related to product integrity, including visual inspection of components and finished goods, manual and semi-automated packaging, and product labeling.
Understanding of basic chemical and biological safety procedures.
Basic knowledge of formulation, filling, and kitting operations and capabilities.

Responsibilities

Work in 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.
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.
Operate large machinery and monitor automated.
Handle hazardous wastes per company procedures and regulatory requirements.
Perform daily arithmetic calculations for volume and concentrations.
Perform daily unit conversions for gravimetric and volumetric measurements.
Operate production equipment such as pipettes, balances, pH meter and heat sealers.
Monitor department equipment for proper operation 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 SOPs.
May author MFG NCRs and risk analysis memos.
Receive and distribute supplies into the production area as necessary.
Perform NetSuite transactions, issue material, completion and closing of work orders.
This position may require local travel between company facilities within a short distance.
May assist with review of quality assurance logbooks.
May perform other duties as assigned.