Quality Control Associate, Microbiology

Job Description

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, subject to applicable eligibility requirements.

Medical, Dental, and Vision Insurance

Company-Paid Life Insurance (1x Annual Salary)

Voluntary Life Insurance Options

Short-Term and Long-Term Disability Insurance

Flexible Spending Account (FSA) & Health Savings Account (HSA)

401(k) Retirement Plan with Company Matching

14 Days of Paid Time Off (PTO)

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

Combination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences)

Minimum three (3) years' experience in Quality Control and environmental monitoring of GMP facilities

High intelligence and problem-solving skills

Excellent oral and written communication and listening skills

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

Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred

General knowledge of one or more of compendial methods such as: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methods

Knowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferred

Direct experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired.

Experience with transfers and qualification/validations of large molecule focused analytical methods

Must have experience with Microsoft Office applications

Experience with quality software and 21 CFR 11 applications preferred

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.

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.

Full-time