Microbiology Quality Assurance Specialist

2 weeks ago

Worcester, Massachusetts, United States AbbVie Full time

Company Overview

At AbbVie, our commitment is to innovate and provide transformative medical solutions that address significant health challenges today and in the future. We aim to positively influence lives across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For further insights about AbbVie, please visit our website.

Job Overview

The Microbiology Quality Assurance Specialist is responsible for executing both routine and specialized testing within a Good Manufacturing Practice (GMP) environment. This position involves conducting laboratory analyses to support various stages of product development, including raw materials, in-process assessments, final product evaluations, stability studies, and validation processes. The Specialist interprets analytical data, assesses outcomes, and draws conclusions with minimal external guidance. This role requires the identification of laboratory methodologies or instrumental anomalies that may affect the validity of test results. The Specialist is expected to troubleshoot moderately complex technical issues, draft procedures with limited supervision, analyze data trends to enhance assay performance, and competently document all types of exception reports. While working under the general oversight of a supervisor, the Specialist is adept at managing their own schedule to ensure the timely completion of assigned tasks.

Key Responsibilities:

  • Conducts intricate testing methodologies as specified to facilitate product/material release with high accuracy.
  • Possesses a thorough understanding of laboratory techniques and principles employed.
  • Evaluates experimental data for compliance with product/material specifications.
  • Implements and upholds GMP standards concerning laboratory documentation, protocols, and systems in alignment with procedural guidelines.
  • Assists in the development and execution of validation assays according to approved protocols.
  • Effectively performs a variety of laboratory techniques for which training has been provided, ensuring minimal error.
  • Proposes enhancements for process optimization.
  • Drafts and revises procedures as required, providing necessary support for the department.
  • Creates and maintains trend reports, backlog reports, and documentation error reports to support departmental performance metrics.
  • Composes all types of investigations and deviations proficiently and aids in troubleshooting assays.
Qualifications

Required Qualifications:

  • Bachelor's degree in Chemistry, Biochemistry, Medical Technology, Biology, or a related scientific discipline.
  • 5-8 years of experience in Quality Control Microbiology or a related field.
  • Maintains necessary certifications for assigned responsibilities.
  • Experience in validating and verifying compendial testing methodologies.
  • Familiarity with microbial testing techniques (e.g., bioburden, endotoxin, microbial identification, and environmental monitoring).
  • Previous experience collaborating within cross-functional teams is preferred.
  • Experience in writing investigations is advantageous.

AbbVie is an equal opportunity employer, dedicated to maintaining integrity, fostering innovation, transforming lives, serving our community, and promoting diversity and inclusion. We are committed to hiring qualified individuals of the highest caliber without discrimination based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected status.

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