Quality Control Associate, Microbiology

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.

Specific Responsibilities

The successful candidate will:

  • Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits
  • Support 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 no 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

General Responsibilities

  • 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

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: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methods

Education/Qualifications

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

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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

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.

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