Lehigh Valley, PA
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.
- 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.
- 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.