Quality Specialist – Lab Operations
Azzur Labs, a growing company and Best Places to Work winner, is seeking a Quality Specialist for it's Lehigh Valley, PA based operation. The company provides quality analytical services to the pharmaceutical, biotechnology, medical device, and other industries and offers the opportunity to cross-train, advance within, and become part of an engaging and positive team environment.
Responsibilities
- Reviews laboratory generated documentation – logbooks, temperature logs, training records, reports, etc.
- Maintains controlled forms, SOPs, Protocols, etc., and issues, files, stores and archives all documentation.
- Coordinates and assists with the change control (CC) and CAPA program.
- Orders laboratory and office supplies and checks for expired materials as part of inventory control.
- Handles Asset Management including equipment acquisition, schedules calibrations/preventative maintenance ships equipment/materials to client sites and conducts verifications as needed.
- Drafts client notifications and releases test results to clients.
- Approves and conducts quality control testing of incoming materials.
- Recognizes and reports Out of Specification results, out of trend results and deviations to the supervisor.
- Accurately maintains logbooks and files compliant with current GMPs, ISO 17025 and internal procedures.
- Observes all safety procedures and regulations.
- Other job-related tasks as required.
Requiements
- BS degree; Quality related certifications and/or training preferred
- At least two years related experience in microbiology laboratory; including Document Control/Review
- Working knowledge of Laboratory operations and equipment; experience with MS Word and MS Excel.
- Excellent attention to detail; strong organizational, communication and documentation skills
- Ability to effectively work independently and provide support in a fast-paced, team environment
