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QC Microbiology Analyst

Date: Feb 19, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

 

The Quality Control Microbiology Technician will perform cGMP testing to support manufacturing activities by primarily performing viable and non-viable environmental monitoring and gown training & qualifications. In addition, the technician will assist with QC analytical method transfer, method suitability testing, and validation. Testing will include, but is not limited to: viable and non-viable environmental monitoring, plate incubation and reads, gown qualification training, particulate testing, growth promotion, ID/gram stain testing, and sterility testing according to documented procedures. Opportunities to support additional Microbiological testing would include endotoxin and bioburden testing.

This position will support facility qualification, validation and routine testing of microbiological assays. The selected candidate will assist in the development and implementation of new programs that govern general and microbiology specific practices, initiate and participate in Alert/Action investigations, create and revise SOP’s and reports as necessary. He or she will ensure compliance with current regulatory requirements (USP, EU, ICH and FDA guidance), good documentation practices (cGDP) and industry best practices for manufacturing (cGMP).

 

Responsibilities

% of Time           Job Function and Description

60%       Environmental Monitoring, Plate Incubation, Reads and Documentation, Support Facility Qualification

20%       Alert/Action Investigations, Data Entry, Laboratory Organization and Cleaning

10%       Gown Qualification and assist with Gown Training Program

5%         Endotoxin/Bioburden/Growth Promotion Testing & Reads

5%         Support analytical method transfer, method suitability testing & validation activities

 

Requirements

Bachelor’s Degree in Biology/Microbiology with 2-5 years ;  -OR- MS Degree in Biology/Microbiology with 2+ years of hands on experience performing Microbiological environmental monitoring tasks such as:

•            Non-viable particulate counts, viable air samples, surface sampling, plate incubation, plate reads, and gown qualification training and sampling.

Previous laboratory experience performing gram stains, identifications, sterility testing, endotoxin and bioburden testing is preferred but not necessary.

Experience maintaining an audit ready laboratory preferred.

Experience with sample handling, data entry, scanning and filing.

Experience with biopharmaceutical products or vaccines a plus.

 

Competencies

 

Excellent communication skills, both oral and written.

Ability to multi-task and work in a regulated environment under set timelines.

 


Nearest Major Market: Philadelphia