Microbiologist

Location: Waltham, MA

Job Description

Hailed as a “Best Place to Work” year over year, Azzur Labs provides quality analytical services to the pharmaceutical, biotechnology, and medical device industries. Azzur Labs is a growing company that offers the opportunity to cross-train, advance within, and become a part of a close-knit team. The right candidate must be detail-oriented, have strong analytical skills, the ability to work independently and maintain the workplace.

Prior to deployment to our Boston Area laboratory, the Azzur Labs Microbiologist will complete a two to three-month training at our state-of-the-art analytical lab headquartered in the Lehigh Valley, PA. Overseen by our highly skilled and award-winning staff, the in-depth and hands-on training encompasses a comprehensive curriculum aimed at providing outstanding service to our far-reaching customer base.

The Microbiologist is responsible for ensuring that laboratory testing is completed in accordance with established methods and protocols, interacting with clients, and interpreting results. At least 3 years of experience required in cleanroom environmental monitoring, USP and EUpH purified and WFI water testing, population verification of biological indicators, media preparation, QC testing of incoming materials, bacterial and mold identification, media fill analysis, growth promotion of media and culture maintenance. Ideally, the candidate will have the following experience: compressed air testing, USP <61> and <62> testing, USP antimicrobial effectiveness testing and USP suitability testing.

Must be able to work holidays and after hours based on client needs and testing requirements. Must understand GMP requirements and documentation practices.

Primary Responsibilities

  • Design, implement and conduct internal laboratory studies.
  • Interact with clients on an as-needed technical basis under guidance from a supervisor. Advise and consult with regard to testing methods, interpretation of results and suggest additional and/or alternative testing or methods.
  • Collaborate with the implementation, maintenance, and improvement of quality systems.
  • Assist with training personnel, develop training materials and formats as directed by management.
  • Review and maintain records for compliance with laboratory specifications.
  • Assist with investigations into the impact on laboratory operations resulting from observations, deviations and equipment failures.
  • Understand the significance of deviations found with regard to the normal use of materials tested.
  • Collaborate in drafting, executing and reviewing of qualification, validation and calibration reports.


Requirements

  • Knowledge and ability to effectively conduct the review and manage quality systems in a professional, ethical and objective manner using and interpreting applicable standards/requirements, with an awareness of potential legal and financial ramifications.
  • Ability to effectively plan, develop, communicate and execute an audit within a defined scope, including resource scheduling, conducting necessary meetings in performance of the audit and using appropriate auditing techniques.
  • Ability to verify, document and communicate review results, as well as evaluate the effectiveness of corrective action/follow-up.
  • Possesses interpersonal skills to resolve conflict, conduct interviews and make presentations effectively.
  • Participates in, leads and facilitates teams.
  • Understands how quality principles relate to business processes and can explain the importance of aligning the quality function to the organization.
  • Must be able to select and use a wide variety of quality tools and techniques in practical applications.
  • Bachelor of Science, or Bachelor of Arts in the field of the life sciences.
  • Experience working in a GMP Microbiology Laboratory