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.
