Microbiology Lead QC

Job Locations US-NJ-Florham Park
ID
2020-1243
Category
Quality Control
Type
Regular Full-Time

Overview

Come join us at our new state-of-the-art facility in Florham Park NJ!  The Microbiology Lead QC is responsible for providing oversight of Microbiology team staff members by ensuring daily microbiology testing is correctly scheduled and completed to support release of clinical and commercial products.  The required testing includes but is not limited to Environmental Monitoring (EM), growth promotion, endotoxin, plate reads, and microbial identification.  Perform routine microbial analysis to detect microbial content on test articles and on samples collected throughout the laboratories to obtain information on types, levels, and control of contamination as needed to support laboratory staff.  Interpret and review of microbiology testing data.  Participate in gowning qualifications, Aseptic Process Simulations (APS), Environmental Monitoring Performance Qualification (EMPQ),  In addition, assist with development of new microbiology related testing methods in-house and training of personnel.  This opportunity presents the ability to independently perform responsibilities in compliance with Celularity’s procedures, federal, state laws, and in accordance with current Good Manufacturing Procedures (cGMP), USP and other regulatory agencies.  Generate and evaluate trend reports to determine corrective actions as needed and also analyze data to provide appropriate next steps.  Composes procedures, protocols, final reports, investigations and associated Corrective and Preventive Actions (CAPAs). 

Responsibilities

Microbiology

Supervise and participate in testing of various samples including in-process sample, final product, and stability samples.  Oversee growth promotion studies for media.  Direct performance of sub-cultures and spiking studies as needed.   Use micro background to assist with development of microbiological testing methods and the proper use of corresponding laboratory equipment.  Provide support as a technical lead on microbiological concepts and techniques, i.e. training and development of laboratory personnel, test validations, and method qualifications.  Participate in aseptic process simulations and gowning qualifications.

 

Environmental Monitoring Program:

Schedule and support collection of  environmental monitoring samples throughout controlled, classified laboratory environments.  Ability to sterile gown for ISO 7 classified cleanroom and knowledge of general cleanroom behavior.  Knowledgeable on the use of environmental monitoring equipment and other associated equipment.  Check and maintain lab inventory.  Initiates and performs Investigations/CAPAs for all microbial testing.

 

Visual Inspection:

Contribute to development or modifications of visual inspection paradigm.  Execute visual inspection process within specified timelines including data evaluation for accuracy and completion.

 

Data Review:

Perform peer review of testing data. Review all data in accordance with applicable procedures, release timelines, and cGMP requirements.  During review, apply scientific knowledge and abilities to ensure all testing is performed in a compliant manner.  Communicate effectively with colleagues and demonstrate teamwork to efficiently complete corrections required.

 

Training:

Train all new personnel to general job duties.  Complete necessary training to become a qualified trainer.  Document training per procedural and cGMP requirements.

 

Quality Systems Support:

Support continuous quality improvement projects.  Learn applicable regulatory guidelines and support developing, authoring, and implementing methods, protocols, reports, and other related documents.  Support document revision, project, CAPA, and investigation/ deviation related tasks.  Assigned tasks within a deviation, CAPA, or project.  Provide frequent and effective communications with management team regarding task completion, roadblocks, and needs.  Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.  Maintain laboratories in an audit ready state.

 

General:

Performs other tasks as assigned and act as support staff to cover other QC functions.

 

Working Conditions

The role will analyze numerical values on a daily basis and will be working in a professional laboratory environment around biohazardous materials, including chemical agents, up to seven (7) hours per day.  The role iwill be required to lift and/or carry up to 25 pounds.  Flexible scheduling required as your shift will be fixed according to business need.

 

Qualifications

  • Bachelor’s or Master’s degree in Microbiology, Biology, Chemistry, Biochemistry or other scientific discipline required.
  • Minimum 7+ years of relevant work experience in pharmaceutical, biologics, microbiology, sterile manufacturing, or medical device industry.
  • Previous people supervisory experience strongly preferred.
  • Knowledge of cGMP and an understanding of the concepts of GLP, FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. USP, EU, etc.) regarding microbiology testing requirements.
  • Strong background in facility EM/microbial control and expertise with microbial techniques, investigations, and detection of microbial trends.
  • Experience with development, qualification, and implementation of microbial methods including strong expertise of microbiological and EM test methods required.
  • Extensive testing experience is required as this position is a lab-based/ hands-on role.
  • Experience with routine gowning qualifications, APS runs, EMPQ, and control of contamination activities is preferred.
  • An equivalent combination of education and experience may substitute.
  • Experience working in aseptic clean room environments and with cell therapy products is strongly preferred.

 

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