The Quality Control Microbiology Technician supports facility and manufacturing activities by sampling, detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems, within the environment and equipment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

Responsibilities

• Responsible for sampling and testing of water systems


• Perform Environmental Monitoring (EM) within classified manufacturing space


• Perform EM of equipment


• Perform Endotoxin Testing on buffers and water


• Perform Bioburden Testing on buffers and water


• Perform media growth promotion testing


• Perform routine and non-routine Microbiological and Analytical Microbiology sampling and testing, which may include environmental monitoring (viable air, viable surface, total particulates), clean utility sampling and testing (conductivity, TOC, bioburden), microbial identification


• Perform plate reading, streaking, gram staining, microbial identification


• Aid in training and certification of aseptic gowning qualifications


• Update microbiological EM database and prepare EM reports as requested


• Perform maintenance of EM database as well as EM trending


• Take on responsibility of plate incubations and be able to perform plate enumeration to attain final viable EM results


• Document non-conformances and participates in investigations resulting from EM excursions


• Make detailed observations in support of Alert, Action, and OOS result investigations


• Collect, document and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results


• Enter test results and compare against established limits and Specification to ensure compliance


• Review and approve test results against established limits and Specifications


• Communicate testing results and disposition to QC Supervisor as required


• Support data generation and trending of all testing performed

Required Skills

• Working knowledge of aseptic practices and techniques


• Basic understanding of FDA/MEA regulations


• Ability to effectively communication with team members


• Ability to multi-task


• Detail oriented


• Ability to work independently and as a team member

Must-Haves

• 2+ years’ experience in microbiology or relevant QC experience in a GMP laboratory setting preferred


• B.S. in microbiology or related scientific field preferred


• High school diploma required

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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