Corporate Overview
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Benefits and Pay Range
Pay range for this position is $21.00 - $27.00 per hour, depending on experience. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. This is a temp to hire position.
Position Overview
The Manufacturing Technician II/III is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. The Manufacturing Technician is expected to fully participate in both departmental projects and any quality working teams which may be applicable. existing procedures. All of the specific requirements presented in this job description are applicable to the functional area in which it resides.
This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. The scheduled start time for this position is either 6:00 AM or 12:00 PM, depending on business needs, with a consistent schedule once assigned. Any exceptions to the assigned schedule must be approved by the manager in advance.
Responsibilities and Duties
- 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.
- 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.
- Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- 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).
- May need to be an author for any MFG 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.
- This position may require local travel between company facilities within a short distance (approximately 3 miles) based on business needs.
- May assist with review of quality assurance logbooks.
- May perform other duties as assigned.
Education Requirements
Level II
- Bachelor's degree in a related field (Biotechnology, Molecular Biology, or Biochemistry) with at least 1 year of work experience at Argonaut or in manufacturing within a cGMP environment; Associate's degree in a related field; or High school diploma/equivalent with 3+ years of related manufacturing experience in a cGMP environment.
Level III
- Bachelor's degree in a related field (Biotechnology, Molecular Biology, or Biochemistry) with 2+ years of work experience at Argonaut or in manufacturing within a cGMP environment; Associate's degree in a related field with 3+ years of related experience; or High school diploma/equivalent with 5+ years of related manufacturing experience in a cGMP environment.
Required Skills and Knowledge
- 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.
