Quality Control Associate, Microbiology
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. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
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.
The QC Associate, Microbiology:
- Manages an environmental monitoring program for GMP Fill/Finish manufacturing.
- Initiates and participates in the investigation of environmental monitoring excursions and assesses potential impact on product quality.
- Supports a Gowning Qualification Program for all manufacturing and QC personnel.
- Supports assay transfer, qualification, and validation activities for microbial based assays.
- Assists where needed to support the overall Quality Control effort such as routine compendial assays, raw material inspection and release.
The successful candidate will:
- Manage environmental monitoring data and generate quarterly and annual reports.
- Establish bioburden and endotoxin testing program for both Drug Product and USP Purified Water.
- Maintain a functioning QC Microbiology Laboratory, including material ordering, inventory control, general housekeeping and other duties.
- Serve as a subject matter expert for internal and external customers.
- Participate in inspection readiness activities.
Position Requirements and Experience
The desired candidate will have:
- 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: pH, conductivity, osmolality, Refractive Index, or TOC.
- Bachelor’s Degree in a relevant discipline (e.g., microbiology, chemistry, or biological sciences).
- Minimum five (5) years’ experience in Quality Control and environmental monitoring of GMP facilities.
- Knowledge in environmental excursion investigations, root cause analysis, and knowledge of cleanroom practices is preferred.
- Direct experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired.
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.
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