Quality Control Microbiology Scientist

QC Microbiology Scientist

Aldevron Quality Statement

All employees of Aldevron are expected to be conscientious, self-motivated professionals, courteous to fellow staff members and clients, and to consistently perform their duties in a manner of the highest quality. Each individual working for the company has the responsibility for assuring the integrity and quality of the products and services the company provides.

POSITION DESCRIPTION

Department: Quality Control (Clinical Grade)

Reports to: Microbiology Manager

Classification: Exempt

Position Summary

The QC Microbiology Scientist will be responsible in performing Microbial risk assessments for environmental monitoring, in process and final product isolates found at the Aldevron Fargo facility. Responsibilities will also include providing guidance on subculture medias and techniques, partaking in the environmental action committee, performing method optimization and method development/method validation as needed for microbiology related methods, assistance in Microbial investigations, and providing guidance on contamination control strategies.

Essential Functions

• Ensure that methods are robust and fit-for-purpose.
• Perform Microbial risk assessments (objectionable/not objectionable) for all above action level excursion at the Aldevron site.
  • Research organisms of concern
  • Provide scientific justification based off literature on why organism is objectionable or non-objectionable.
  • Provide guidance on growth medias for difficult to subculture organisms
• All employees are responsible for the general upkeep of work and shared spaces
• Identify new techniques and instrumentation to expand internal capabilities. Prepare justification for new lab equipment.
• Research organisms of concern
• Develop, write, and assist with new microbiology methods/protocols by providing guidance, supervising the work of analysts or through collaboration with other groups, including contract testing laboratories.
• Perform other duties as assigned
• Lead activities associated with method validations and transfers including development of validation strategies to meet regulatory requirements.
  • This includes authoring qualification, validation, and verification protocols; analyzing results against pre-determined acceptance criteria; and authoring final reports
• Identify root causes based off data and investigations.
  • Including advising on remediation of organisms detected.
• Review statistical data for trends
• Assist in contamination control initiatives throughout the site
  • Participate in Environmental Action Committee
  • Review statistical data for trends
  • Draft trend reports
  • Identify root causes based off data and investigations.
    • Including advising on remediation of organisms detected.
• This includes authoring qualification, validation, and verification protocols; analyzing results against pre-determined acceptance criteria; and authoring final reports
• Provide scientific justification based off literature on why organism is objectionable or non-objectionable.
• Provide guidance on growth medias for difficult to subculture organisms
• Punctual and regular attendance is required of all employees
• Draft trend reports
• Contribute to Quality Event reports for Out of Specification (OOS) investigations or other laboratory investigations including Root Cause determination and Corrective Actions and Preventative Actions (CAPA), as needed
• Including advising on remediation of organisms detected.
• Participate in Environmental Action Committee
• Provide training to analysts for newly developed methods that are ready for validation
• Create, revise, and finalize standard operating procedures (SOP), product specifications, and other GMP documents

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the position.

Supervisory Responsibility

N/A

Travel

N/A

Qualifications

Experience:

• Minimum 4 years of experience working in a microbiology laboratory environment in a contamination control role or equivalent.
• Experience in performing microbial risk assessments
• Experience in assay development, optimization, experimental design, and data analysis, preferably in a GMP environment
• Understanding of MicroSEQ, Maldi-TOF, Gram staining, other microbial identification platforms.

Education

• BS. in microbiology or related scientific field with 4+ years of relevant experience. preferred. Master’s degree with relevant work experience.

Skills & Knowledge

• Knowledge of regulatory documents including ICH, USP, EP, and FDA guidance documents
• Familiarity with data collection and management software such as electronic laboratory notebooks (ELN) and LIMS is a plus
• Previous experience with contamination control
• Strong background in MicroSEQ and organism identification
• Previous GMP experience is highly preferred.
• Strong background in microbial risk assessment
• Experience in microbiology method validations and transfers is highly preferred.

Abilities

• Ability to work on cross functional teams.
• Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity, and innovation
• Demonstrate high ethical standards, trustworthiness with strong communication and leadership skills

Working Conditions

This position works in a Clinical or Research Grade lab setting and may come in contact with various solutions and chemicals and will be responsible for activities related to biological processes such as bacterial growth. This position may use standard laboratory equipment such as pipettes, centrifuges, glassware, shake flasks, fermenters, fume hoods, and computers.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.

EEO

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.