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, Environment and Safety regulations
- May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
- Other incidental duties
**Education and Experience**:
Associate's Degree or equivalent with 5 years of previous experience working in a laboratory environment. Required.
Or Bachelor's Degree or equivalent in Chemistry Preferred.
Work Shift
Availability to work from Monday to Friday 8.00 a.m. to 5.00 p.m.
**Additional Skills**:
- Able to read, comprehend, write and speak English
- Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation, Empower) preferred
- Full knowledge of laboratory processes
- Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
- Full knowledge in mathematics, e.g., decimals and percentages
- Ability to write technical documents
- Strong knowledge with ISO microbiological sterilization documents if applicable
- Strict attention to detail
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- 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
