JOB DESCRIPTION:
- Update and maintain validation database.
- Maintain and create validation protocols in KNEAT.
- Write and/or modify procedures to support quality compliance; provide follow-up training, as needed.
- Meet routinely as a Quality Systems Team to discuss validation schedules and system updates.
- Able to quickly retrieve and understand data to validate results.
- Work cross functionally on project closure.
- Support Performance Qualification execution.
- Support SOP development
- Assist in improvement of key Quality systems including but not limited to: Product Conformance, Raw Material & Product Traceability, Receiving, Storage, & Handling, SAP system, and Internal / External Audits.
- Generate Quality Assurance Control reports as delegated by the QA Department.
- Ability to climb, crawl and kneel as needed to perform the functions of the job.
- Ability to sit for extended periods of time.
- Ability to lift up to 50 lbs.
- Ability and able to adhere to all safety and EOHS standards, and wear and utilize all personal protective equipment when needed.
Other Required Experience/Qualifications:
- Minimum 1-2 years Project Management experience.
- Minimum 1-2 years in Manufacturing experience.
- Willing and able to work Monday - Friday from 8AM-4:30PM
- Advanced computer skills including database management and process control, Microsoft Office (Word, Excel, etc.) and Google Suite (Docs, Sheets, etc.) applications.
- Effective communication skills.
- Ability to work independently as well as within a team setting.
- Experience working in Quality Control or Quality Systems.
- Ability to relate, compare and validate data from different sources.
- Able to multitask, handling a variety of assignments at the same time.
- Some knowledge of cGMPs, Quality Standards, FSMA Preventive Controls, HACCP preferred, but not required