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Sr Quality Control Microbiology Technician
Job Opportunity at
Spark Therapeutics, Inc
Posted on Dec 12
The senior quality control microbiology technician will perform cGMP testing to support manufacturing activities by primarily performing environmental monitoring, gown training & qualifications, and microbial testing. This position will support facility qualification, validation, and routine testing of microbiological assays. The selected candidate will be accountable to communicate and lead Alert/Action investigations, create and revise SOP’s, forms, logbooks, 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).
Testing will include, but is not limited to:
viable and non-viable environmental monitoring
plate incubation and reads
ID/gram stain testing
and sterility testing according to documented procedures.
Environmental Monitoring, Plate Incubation, Reads and Documentation, Support Manufacturing Operations
Alert/Action Investigations, Data Entry, Document creation and revision, Trending
Endotoxin/Bioburden/Growth Promotion Testing & Reads
Excellent communication skills, both oral and written.
Ability to multi-task and work in a regulated environment under set timelines.
Experience communicating across functional teams: Lab management, Manufacturing Operations, Quality Assurance.
Bachelor’s Degree in Biology/Microbiology with 4-6 years related experience ; -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.
Experience maintaining an audit ready laboratory preferred.
Experience with sample handling, data entry, scanning and filing.
Experience with biopharmaceutical products or vaccines a plus.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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