- Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
- Map each process in the assigned laboratory and look for ways to streamline/improve.
- Write and execute validations for manufacturing processes and laboratory instruments and methods as needed.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Work successfully on cross functional projects & teams.
- Off shift work as required. List knowledge, skills, and/or abilities required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- bility to handle multiple tasks concurrently, and in a timely fashion. Computer literate.
- Must be able to communicate effectively with managers, peers, and subordinates.
- Strong leadership, organizational and time management skills, and ability to handle multiple tasks.
- Must demonstrate effectiveness in ability to train others, empowerment, results orientation, and task completion.
- Decision-making and technical problem-solving ability is a plus.