Quality Specialist

Location: Lehigh Valley, PA

Job Description

Azzur Labs is looking for a Quality Specialist to provide 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.
 


Ideal Qualities

  • Strong writing and problem-solving skills. 
  • Excellent attention to detail; excellent organizational skills. 
  • Excellent interpersonal skills; ability to communicate effectively with all personnel. 
  • Ability to be a strong team player, demonstrated through attitude and behaviors. 
  • High level of integrity/ethics and strong commitment to quality 
  • Willingness to learn and a desire to enhance knowledge of the Quality profession.. 
  • Ability to read and follow directions, complete paperwork and communicate effectively


Essential Duties and Responsibilities

  • Review of all laboratory generated documentation - logbooks, temperature logs, training records, reports etc.
  • Maintains control of all controlled forms, SOPs, Protocols, etc. Issues, files, stores and archives all documentation.
  • Accurately maintain logbooks and files compliant with current GMPs , ISO 17025 and internal
  • Assists with the change control and CAPA program.
  • Quality Procedure/ SOP, including review and investigation.
  • Reviews all client notifications and releases test results to clients
  • Approves quality control testing of incoming materials.
  • Recognize and report Out of Specification results, out of trend results and deviations to the supervisor.
  • Observes all safety procedures and regulations.
  • Other job-related tasks as required.


Qualifications

  • Bachelor Degree in a Science Field. (Chemistry preferred)
  • Minimum two years Quality assurance experience
  • Minimum two years’ experience with document Control/ Review
  • Working knowledge of MS Word and MS Excel.