Quality Control Associate

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. 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

Benefits for this position are available, subject to applicable eligibility requirements. These include:

• Medical, Dental, and Vision Insurance

• Company-Paid Life Insurance (equal to 1X annual salary)

• Voluntary Life Insurance Options

• Long-Term and Short-Term Disability Insurance

• Flexible Spending Account (FSA) and Health Savings Account (HSA)

• 401(K) Retirement Plan

• 14 Days of Paid Time Off (PTO)

• 10 Paid Holidays Annually

The pay range for this position is between $33.00 - $45.00 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.

Position Overview

The purpose of this position is to provide support services by means of executing the analysis of in-process, finished product, and stability test samples. Further support services include Environmental Monitoring and Raw Material receipt activities. QC personnel are responsible for compliance with QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control.

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.

Responsibilities and Duties

• Execute incoming inspection of raw materials in accordance with company policy and procedures

• Conduct environmental monitoring for the facility on a routine basis per applicable SOPs including sampling of the USP Purified Water system and associated plant utilities

• Assist in the expedition of test sample shipment to sponsors and 3rd party laboratories

• Execute deviation/OOS investigations and implement CAPAs and change controls per GMP requirements, as needed

• Assist in the execution of analytical method transfer activities, including product-specific test methods

• Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines

• Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications

• Assumes the role of safety liaison with EHS and Safety Officer

• Assists QA in calibration/preventive maintenance activities associated with lab instrumentation

Requirements and Qualifications

• Undergraduate degree (B.A. or B.S.) in a Life Science discipline

• 3-4 years' GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields

• Direct experience with EM sampling and aseptic technique

• The ability to perform daily tasks with a keen attention to detail

• An affinity for precise and detailed documentation skills

• The ability to work effectively and contribute to a dynamic and fast-paced work environment

• Well-developed oral communication and listening skills

• Applicable academic or industrial laboratory experience

• High-level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction

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.