Laboratory Technologist I, Microbiology (Tuesday-Saturday, 8am-4pm)
Job Location US-PA-Jessup
Type Full-Time
Category Quality
Shift 1st Shift
Job ID 2013-1844
More information about this job:
Overview/Risks:
The Laboratory Technologist I is responsible for ensuring that test method
execution is performed to validated microbiological testing procedures and that
MTF, AATB, FDA, USP, TGA and regulatory standards are met. The Laboratory
Technologist I is the primary support function for test methods involving
Bioburden Testing, DNA Genetic Analyzers, Phylogenetic Data Interpretation and
Extrapolation, CAP Certification, Sterility Testing via Membrane Filtrations, ERA
Certification, Environmental Swab Testing, Media Growth Promotions, Colony
Morphological Identification for Prokaryotes and Eukaryotes as it relates to
purified isolated organisms. All operational procedures are performed to ensure
customer service between contract laboratories and departments within MTF.
Responsibilities:
* Responsible for primary support for test methods as listed above following Micro Lab systems of operation, current Good Laboratory Practices (cGLPs), current Good Manufacturing Practices (cGMPs) as well as current and approved Micro Lab operating procedures (OPs) and work instructions (WIs).
* Places on-test all Bioburden (IPBB) samples received from Jessup IPBB Laboratory and contract laboratories. Purifies culture isolates for speciation using 16S rDNA Genetic Analyzers.
* Reconciles all samples received from MTF facilties, Jessup IPBB Lab, and contract labs and maintains chain-of-custody documentation accordingly.
* Maintains CAP certification and performs quarterly proficiency testing for microbial and fungal isolates using the 16S rDNA Genetic Analyzer.
* Performs all 16S rDNA preparation for Genetic Analyzer utilizing PCR (polymerase chain reaction) methods with various validated calibrated pipettes, centrifuges, thermocyclers and gel-electrophoresis plates according to validated procedures using appropriate speciation methodology techniques (i.e. Koehler Illumination and measurement devices such as ocular micrometer to measure isolates, conidia, spores, etc).
* Maintains ATCC certified stock cultures for quality control, growth promotions, or investigation procedures if required. Supports maintenance of stock cultures including growth promotion test data, log books, and spreadsheets in accordance with SOPs, FDA, USP, and CAP regulations.
* Maintains long term fungal cultures for investigation procedures if required.
* Performs maintenance on Genetic Analyzers as well as maintains computer files and data back-up required for large files.
* Performs biochemical tests such as API and Rapid ID kits for confirmatory reporting if required.
* Performs final speciation and identification on all environmental positive plates, swabs, slants, broths, and membrane filtration filters.
* Performs micro-plate reader assays or analytical tests for back-up to Laboratory Analysts if trained and required.
* Perform IPBB validated testing using temperate media, sonication procedures, and aseptic pipette techniques within biological safety cabinets if trained and required.
* Performs sample, standards, stock cultures, media and dilution preparatory work as needed.
* Assists in the qualification of test methods and equipment qualifications.
* Performs data review for sample throughput daily.
* Annually reviews all OPs and WIs in Master Control for necessary testing and analyses.
* Assist with routine Micro Lab operations on weekends, holidays and overtime when required.
* Performs additional duties as assigned.
* Actively cooperates in training and retraining due to operation changes, document updates, or when required.
Qualifications:
MINIMUM JOB REQUIREMENTS
Education:
B.S. in Biology, or Microbiology.
Experience:
Minimum of 3 years experience in a clinical or industrial laboratory setting required with experience in bacteriological and fungal identification systems and colony morphology.
Specific Licenses and/or Certifications:
CAP of ASCP Certification.
Specialized Knowledge, Skill, and Abilities*:
Proficient in most microbiological methodologies and test procedures applicable to testing performed in the Microbiological section.
Computer Literate in Microsoft Office, Microsoft Outlook and LIMS database.
Knowledge of GLPs/GMPs, FDA and USP regulations, Laboratory Standard Operating Procedures (SOPs), and basic statistical methods required.
Strong troubleshooting analysis and techniques within an environmental or clinical laboratory setting required.
Work Environment:
Able to work in a fast-paced, high volume, team environment. Must be articulate, well organized, and able to work independently as well as with others.
Physical Demands:
(if applicable)
Capable of lifting 50 lbs.
PREFERRED QUALIFICATIONS
Education:
B.S. in related science with certifications in Medical Technology.
Experience:
5+ years experience in a clinical or industrial laboratory setting required with experience in bacteriological and fungal identification systems and colony morphology.
Specific Licenses and/or Certifications:
ASCP Certification and CAP Certification.
Specialized Knowledge, Skill, and Abilities:
Proficient in all microbiological methodologies and test procedures applicable to testing performed in the Microbiological section.
Proficient in PCR and molecular biological methodologies for DNA preparation and sequence data extrapolation.
Computer literate in Microsoft Excel.
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