W-Microbiologist I

AlloSource•Centennial, CO

1d•$20 - $26•Onsite

About The Position

The Microbiologist I provides complete technical laboratory services in support of controlled work area activities, tissue QC laboratory testing, and sample management. Services include environmental monitoring, aseptic donor testing of AlloSource’s tissue products microbiological evaluation and identification, chemical analyses, quality control testing, and analysis of product for compliance and release. The Microbiologist I also performs research, scientific, and technical related projects and experiments as directed by laboratory management.

Requirements

Bachelor’s degree in Microbiology, Medical Technology, or related field
1+ year in medical device, pharmaceutical, or related scientific environment (w/ BS or MS)
1+ year professional Microbiology (or related field) laboratory experience
Experience as a Teaching Assistant in a lab may count towards this requirement.
Proficiency in Microsoft Office Applications
Ability to communicate in English proficiently (speaking, reading, writing and comprehension)

Nice To Haves

AATB certification
ASQ certification
Master’s degree in a scientific field
FDA & CLIA-regulated environment experience
Tissue banking experience
FDA/ISO/CLIA audit experience
Experience in examination of microbial samples

Responsibilities

Perform all elements of the Environmental Monitoring Program, including sampling of non-viable, viable air, personnel monitoring, settle plates, swabs, water, and special testing.
Performing quality control (QC) testing using aseptic techniques and testing practices per applicable standards.
Perform microbial evaluation of environmental monitoring and final QC samples according to established procedures using appropriate laboratory techniques for accurate microorganism identification and interpretation of results.
Perform product-based QC testing, including both microbiological and non-microbiological methods.
Execute appropriate quality control procedures and proper documentation to comply with regulatory agencies.
Participate in CLIA proficiency testing.
Perform timely testing and closure of environmental monitoring paperwork and reports.
Participate with internal, customer, and regulatory audits.
Utilize electronic systems to perform test ordering with third-party and internal laboratories for QC test outputs.
Create inspection plans.
Reconcile QC sample output from Operations group to ensure proper sample requirements.
Coordinate shipments of QC samples to intermediate (sterilization) vendors and external laboratories.
Troubleshoot laboratory testing and submission errors.
Manage QC sample movements and temperature storage locations.
Input and utilize quality system processes for QC output errors.
Responsible for QC sample movement to internal laboratory area.
Coordinate dose audit testing samples with QAL and appropriate Operations groups.
Perform case management and nonconformance activities as determined by team supervisor.
Assist Quality Management in collection of data, analysis of data, and report development.
Assist laboratory scientists and leadership with analytical techniques, written procedures, and standard protocols to support research, scientific, or technical-related disciplines.
Assist in departmental microbial projects (e.g. Method Suitability (Bacteriostasis and Fungistasis testing).
Perform specialty testing and research validation work.
Complies with accurate experimental data entry into notebooks and computer databases.
Interprets and analyzes scientific data into reports and summary documents.
Participate and interact in Aseptic Processing Program meetings, reviews, and project teams.
Professionally interact and communicate with internal and external customers/vendors and process stakeholders.
Perform training, as required, for junior-level technicians.
Assist in the development, evaluation, and review of policies, procedures, and methodologies for the laboratory in order to maintain compliance with accreditation.
Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
May perform other related duties and responsibilities as assigned.