Origin: a Latin derivative
meaning "Gift of the Earth."
- Supervises day-to-day activities performed by QA Techs I and ll.
- Reviews and recommends QA holds, rework, and in-process adjustments.
- Executes product issues, which have Material Review Board dispositions.
- Works with and supports Operation functions,
- Performs batch record review and approval as outlined to product specification.
- Prepares and submits regular reports to Quality Manager by collecting, analyzing, trending and summarizing QA holds, rework, etc.
- Assists with AQL inspections according to written standard operating procedures and specifications.
- Works closely with manufacturing supervisors and leads to ensure collaborative problem solving as issues arise.
- Complies with FDA, cGMP, NHP, TGA and other requirements, enforces adherence to requirements and performs regular trainings for QA day and swing shift techs as well as production team leads to maintain continuous improvement focus.
- Assists with complaint, non-conformance, material review, deviations and CAPA investigations.
- Assists with the development of procedures and forms.
- Serves as back up to QA Manager and QA Techs as needed.
- B.S./ B.A. degree or equivalent experiences 1-3 years supervisory experience and 3-5 years of QA Tech experience in a food, juice, dietary supplement, device or drug facility
- Knowledgeable in Quality Control, Quality Assurance, Document Control, label control, and retain room processes.
- Knowledge and experience with applicable FDA regulation, cGMP requirements, and GLP requirements required.
- Attention to detail and organization of tasks and workloads, Must be able to identify small defects.
- Excellent communication skills in writing, listening, and responding with feedback within quality and production. Must be good at negotiation and conflict resolution.
- Ability to write and implement standard operating procedures in the warehouse facilities.
- Familiarity with basic computer programs: SAP preferred, Microsoft Office suite required