Provide testing services in a laboratory environment.Key Responsibilities:• Perform routine and non-routine testing services by using established procedures/protocols (e.g. manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc.)• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records• Perform investigations on CAPA forms e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval• Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes• Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis• Create and develop validation plans for laboratory equipment and methods• Lead laboratory investigations and propose recommendations and solutions for manager approval• Propose and update operating procedures and ensure that specifications are in compliance with GMP• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures• Other incidental duties assigned by LeadershipEducationTechnical Diploma in Microbiology, Laboratory or Chemistry or Bachelor's Degree in Microbiology. RequiredExperienceMore than 3 years of previous experience working in a laboratory environment or in a microbiology environment . Required.Availability to work in shift A (Monday to Friday 8.00 a.m. to 5.00 p.m.) or shift B (Monday to Friday 3.30 p.m. to 10.30 p.m.)Additional Skills:• Excellent written and verbal communication, interpersonal, and relationship building skills.• Able to read, comprehend, write and speak English (Intermediate level).• Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g. ChemStation Empower).• Full knowledge of laboratory processes.• Knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations• Ability to write technical documents.• Strong knowledge with ISO microbiological sterilization documents if applicable.• Strict attention to detail.• Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments.• Ability to provide feedback in a professional, direct, and tactful manner.• Ability to represent the organization to outside contacts, i.e., vendors.
