Quality Control Microbiology Associate

Posting Date 1 week ago(10/16/2020 10:19 AM)
Requisition ID
2020-8023
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Quality Control Microbiology Associate at Cook MyoSite will perform GMP testing and environmental monitoring to support lot release and in-process testing.

Responsibilities

• Perform GMP lot release and in-process testing for microbiology-based methods such as growth promotion, gram stain, and sterility testing in support of manufacturing processes

• Perform environmental monitoring activities such as collecting viable air, surface EM samples, non-viable particulate samples, reading of plates and trending for EM data

• Use Laboratory Information Management Systems (LIMS) to identify samples to be analyzed and to generate analytical data and enter the data into LIMS 

• Perform EM data review, trending and analysis.

• Maintain instrumentation and supporting documentation in a GMP compliant manner

• Handle and work with microorganisms and maintain facility isolates

• Recommend and establish different methods for performing QC Microbiology tasks

• Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices and cleanroom etiquette 

• Conduct microbiology validation studies, assay qualifications and special projects as assigned

• Support interdepartmental communications when outside testing is required 

• Troubleshoots assay methods and equipment

• Cleaning and General maintenance of side labs

• Aid in activities related to monthly inventories and removal of expired products

• Assist in the investigation of nonconformance activities with additional testing and evaluation activities as needed

• Author quality system records such as deviations and CAPAs.

Qualifications

• Undergraduate degree in Life Sciences, preferably Biology or Microbiology, or related field or 6 years direct, relevant professional experience in microbial analysis to provide a comparable background

• Minimum of 1-3 years' experience in Microbiological Laboratory setting

• Working knowledge of Microsoft Office software

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing preferred

 

Physical Requirements:

• Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

• Ability to spend majority of day standing in laboratory setting or sitting at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis.

 

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