BIO Associate Staff (Medical Factory)

Job Qualifications:

• A graduate of an Engineering course preferably in Chemical Engineering and BS Biology Graduate
• A licensed Engineer is an advantage
• Working knowledge of quality management systems (ISO 9001 / ISO 14001 / ISO 13485) and quality process control is an advantage
• Knowledge of Chemistry Techniques, Lab Environment, Clinical Lab Testing, Sterilization, Equipment Calibration, and Biohazard safety
• At least one (1) year related work experience in a manufacturing firm is an advantage

Job Description: Plans, conducts, and monitors BIO testing to maintain the cleanliness of the production area. Evaluates audit findings, and conducts analysis and investigation to determine the root cause of nonconformities related to the BIO process. Issues nonconformity and implements appropriate corrective actions. Collects and compiles statistical quality data and makes technical reports related to the BIO process. Prepares, revises, and registers work procedures related to the BIO Process. Conducts training for newly hired personnel regarding the work environment and BIO process. Oversees and supervises the work and activities of BIO workers. Makes validation protocol, performs test method validation, and creates validation reports. Reviews test records and monitoring related to the BIO process. Supports on-site audits conducted by external providers and internal audits. Coordinates with external service providers related to BIO processes and pest control. Reports to immediate heads regarding the results or updates on outcomes of the BIO process and activities. Reviews external documents such as regulations, standards, and laws related to the BIO process. #J-18808-Ljbffr