Quality Control Associate, Microbiology

Job Description

Job Description

Corporate Overview

Argonaut Manufacturing Services Inc. is a leading contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for pharmaceutical and biopharmaceutical products. Headquartered in Carlsbad, California, Argonaut supports clients from clinical development through commercial manufacturing, with a focus on product quality, yield optimization, and reliable delivery.

Argonaut provides flexible drug product manufacturing solutions, including vial, syringe, and cartridge filling, as well as combination filling capabilities. The company also offers analytical services and short-term cGMP storage to support clients throughout the manufacturing process.

With a commitment to rigorous quality standards and hands-on client support, Argonaut works closely with customers to help ensure consistent, compliant, and efficient manufacturing while meeting critical timelines and patient needs.

Benefits and Pay Range

Benefits for this position, subject to applicable eligibility requirements.

• 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.

Position and Scope

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.

Responsibilities and Duties

• 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 and accurate results with a client driven focus

• Safely operate laboratory equipment in accordance to established practices and SOPs

• Assist in training of additional team members

• Under minimum supervision, support special projects as needed

• Operates to the highest ethical and moral standards.

• Adheres to quality standards set by regulations and Argonaut Manufacturing Services policies and procedures

• Communicates effectively with supervisors, staff, and clients

• Participate in projects within a team and as an individual

• Support continuous improvement projects related to QC

• Multi-task, prioritize workload, document properly and interpret data accurately

• Follow laboratory safety requirements to promote a safety-first culture

Requirements and Qualifications

• Bachelor's degree or equivalent combination of undergraduate coursework and relevant experience in Microbiology, Biology, Chemistry, Biological Sciences, or a related discipline.

• Minimum 3 years of Quality Control and environmental monitoring experience in a GMP-regulated facility, preferably within a cGMP contract manufacturing environment.

• Hands-on experience with microbiological compendial methods, including endotoxin, bioburden, growth promotion, and sterility testing; direct sterility testing experience highly preferred.

• Working knowledge of cleanroom practices, environmental monitoring, excursion investigations, root cause analysis, and out-of-specification (OOS) investigations.

• Experience with analytical method transfers, qualifications, and validations, preferably for large-molecule products.

• Working knowledge of cGMP requirements and 21 CFR Part 11 applications; experience with quality management systems and electronic quality software preferred.

• Proficiency with Microsoft Office applications.

• Strong problem-solving, organizational, written and verbal communication, and listening skills.

• Demonstrated integrity, professionalism, accountability, and strong work ethic, with the ability to work independently and exercise sound judgment 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 with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.