Quality Control Associate, Microbiology

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.

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Company Paid Life Insurance 1X annual Salary
• Voluntary Life Insurance
• Long-Term Disability Insurance and Short-Term Disability Insurance
• Flexible Spending Account and Health Saving Account
• 401(K) Retirement Plan
• 10 Days of Paid Time Off
• 10 Paid Holidays Annually

The pay range for this position is between $27.00 - $32.00 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.

The purpose of this position is to assist in establishing and managing a microbiology program that oversees aseptic fill/finish activities, environmental monitoring, gowning qualification, and the establishment of compendial microbiology assays that include endotoxin, bioburden, and sterility. The position is responsible for ensuring all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.

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 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

• Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits
• Supports assay transfer, qualification, and validation activities for microbial based assays or clients' specific methods
• Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports
• Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods
• Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.
• Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product quality
• Support a Gowning Qualification Program for all manufacturing and QC personnel
• Perform routine monitoring of pharmaceutical water and gas systems
• Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing
• Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities
• Assist in trending EM data and generate quarterly and yearly reports
• Participate in inspection readiness activities
• Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities
• Provide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties
• Assist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findings
• Operate at a consistent and exemplary level of efficiency, producing high quality…