Environmental Research Microbiologist II

Allosource•Centennial, CO

16d•$72,419 - $84,088•Onsite

About The Position

Would you like to develop your skills working for a mission-driven organization while playing an important role in leading the way in Life Sciences? AlloSource is a BioTech company headquartered in Centennial, Colorado. Here at AlloSource we re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person s life! If this sounds like an organization you wish to be a part of, then we invite you to apply. Summary: The Environmental Research Microbiologist II provides complete technical laboratory services in support of controlled work area activities. Services include environmental monitoring, microbiological evaluation and identification, chemical analyses, quality control testing, and analysis of product for compliance and release. The Environmental Research Microbiologist II also performs research, scientific, and technical related projects and experiments as directed by laboratory management. As a senior level laboratory role, this role will also manage QC testing activities with assigned product line(s), including dose audit, QC data trending, and aseptic processing program requirements.

Requirements

Bachelor s degree in Microbiology, Medical Technology, or related field
4+ years (w/ Bachelor s degree) in medical device, pharmaceutical, or related scientific environment or 1+ years (w/ Master s degree) in medical device, pharmaceutical, or related scientific environment
3+ years Microbiology laboratory experience
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 scientific field
FDA & CLIA regulated environment experience
Tissue banking experience
FDA/ISO/CLIA audit experience

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.
Perform microbial evaluation 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.
Manage sterilization microbiological activities with assigned product line dose audits.
Own assay specifications.
Participate with internal, customer, and regulatory audits.
Manage and execute research activities with analytical techniques, written procedures, and standard protocols to support research, scientific, or technical-related disciplines.
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.
Lead and interact in Aseptic Processing Program meetings, reviews, and project teams.
Assist laboratory management with Environmental Monitoring data trending.
Perform QC data visualization analysis with designated product line(s).
Run assigned process simulation activities with designated product line(s).
Professionally interact and communicate with internal and external customers/vendors, laboratories, and process stakeholders.
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.