QA Specialist

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 Lab, the Azzur Labs QA Specialist 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.

Primary Responsibilities

  • Oversees all aspects of the location’s quality improvement efforts, including developing, improving and administrating the program, training and leading employees, and facilitating change throughout the organization.
  • Implements and maintains quality systems.
  • Performs internal and external audits in a professional, ethical, and objective manner.
  • Ensures all incoming materials are tested and found to be of acceptable quality before use.
  • Conducts investigations of laboratory deviations and client exceeded concern levels.
  • Assists with the CAPA and change control programs.
  • Maintains training records and documentation.
  • Conducts a review of internal methods and protocols.
  • Reviews documentation, such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, regulations and Azzur Labs’ quality systems, as needed.
  • Ensures proper control of laboratory documentation.
  • Possesses relevant knowledge of the technology used for the manufacturing of materials tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service.
  • Understands the significance of deviations found with regard to the normal use of materials tested.
  • Communicates with clients on an ongoing basis to discuss the interpretation of test results, trend analysis and matters regarding exceeded concern levels, follow-ups, and reports.
  • Reviews opinions and interpretations expressed by testing personnel.

Requirements

  • Knowledge of GMP’s and laboratory testing methods for pharmaceutical, medical device, and biotechnology.
  • 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 internal and client audits 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.