Manufacturing Associate - Temporary

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 I 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 I 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 $23.00 - $28.00 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

• Independently investigate author quality event memos such as Non-Conformance Reports (NCR), risk analysis, Deviations, instructions, and other memos.

• Manage documentation changes via MasterControl

• Participate in and champion Continuous Improvements.

• Understanding of manufacturing operations related to formulation, filling, and kitting. Perform calculations converting between volume, weight, concentrations, or other unit of measures. Understanding of significant figures.

• Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply

• Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines etc.

• Operate general production equipment such as spectrophotometers, autoclaves, balances, centrifuges, pH and conductivity meters, label printers, heat sealers, etc.

• Assist in training/leading of new team members in production activities.

• Receive and distribute supplies into the manufacturing areas.

• Manage hazardous waste in compliance with company procedures & State/Federal/Local hazardous waste regulations.

• Assist in revision of standard operating procedures (SOP) and production documents via MasterControl.

• Assist with review of GMP records

• Perform ERP (NetSuite) functions including transactions, material issuance, and completion/closure of work orders.

• Manage equipment add/removals

• May perform other duties as assigned.

Requirements and Qualifications

• Requires Bachelor's degree or AA degree with 2 years of related work experience or a high school diploma with a minimum of 4 years of related work experience. Scientific degree preferred.

• Internal Candidates: The aforementioned requirements are preferred for internal candidates. They must demonstrate the proficiencies/qualifications in order to qualify for the position.

• 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.

• Knowledge of Formulation/Lyophilization operations and capabilities.

• Must be able to monitor semi-automated processes for extended periods and adjust as needed.

• Must be able to perform in-process gravimetric verifications

• Intermediate Computer Skills, Office Suite

• Must be self-motivated and possess the ability to work independently as well as within a team environment.

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.