Manufacturing Associate II

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.

Position Overview

The Manufacturing Associate II is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate II is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products. 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. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

The pay range for this position is between $26.50 - $30.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Responsibilities and Duties

• Manage and update the Kanban System.
• Manage sustaining documentation updates and providing review of NPI documentation.
• Manage equipment lifecycle including generating URS, onboarding and commissioning, generating calibration specifications, SOP and participating in IOQ.
• Perform Preventative maintenance on equipment.
• Must act as SME on multiple processes and be able to provide technical guidance.
• Participate in kitting and design for finished storage of products in shipping containers
• Must identify and implement effective continuous improvements
• Work interdepartmentally to drive lean initiatives
• Lead efforts in troubleshooting, root cause analysis, and corrective and preventive actions (CAPA) for deviations and non-conforming materials.
• Be proficient at NetSuite and able to investigate discrepancies.
• Be proficient at collaborating in MasterControl.
• Collaborate on validation protocol and assist in the execution of validation activities.
• Review manufacturability of NPI prior to execution.
• Perform Label Adhesive compatibility studies.
• Able to be SME and train operators on label generation.
• Be able to back up planning and scheduling.
• May perform other duties as assigned.
  
  

Requirements And Qualifications

• Preferred: Bachelor's degree in a related field (Biotechnology, Molecular Biology, or Biochemistry) with at least 2 years of work experience at Argonaut or in manufacturing within a cGMP environment.
• Associates degree in a related field (Biotechnology, Molecular Biology, or Biochemistry), with at least 3 years of work experience at Argonaut or in manufacturing within a cGMP environment.
• High school diploma or equivalent with 5 years of related in manufacturing within a cGMP environment.
• 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.
  
  

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

Background checks are conducted to support workplace productivity, safety and security by ensuring applicant backgrounds and qualifications are suitable for the position being considered.

It is the policy of Argonaut Manufacturing Services, Inc., as part of its hiring procedures, to conduct background checks on finalist(s) for all positions. These checks will be job-related, consistent with business necessity and conducted pursuant to all applicable laws, rules, policies and procedures. Background checks may include, but are not limited to: verification with educational institutions or licensing/credentialing boards; standard criminal checks, employment verification; and other pertinent information and resources.

Employment offers will generally be made after successful completion of applicable background check(s). However, any offers of employment made prior to completion of the background check(s) shall be contingent upon successful completion of the check(s). Finalist(s) may be rejected if they provide inaccurate, untruthful information, don't fully participate in a required background check, or don't sign or complete a required form.