- Job Level:
Our client is in need of a quality inspector for both 1st and 2nd shift. In this role, you will support manufacturing and packaging for quality-related incidents and cGMP compliance.
- Verification of cleanliness of equipment.
- Release of equipment for use.
- Isolation and evaluation of the suspect products.
- Review of batch records for completeness and compliance.
- Continuous auditing of the facility for cGMP compliance.
- Respond to quality incidents such as OOS in-process results, foreign materials, spills, equipment failure etc.
- Isolate the impacted product.
- Determine the next course of action for continuation of production.
- Communicate and document actions taken.
- Issue supplemental cGMP documentation.
- Training for inspection activities.
- Issuance and management of the supplemental inspection system.
- Gather data for quality assessors and management.
- Gather data for triage processes.
- Participate in triage.
- Identify and update SOP discrepancies as continuous improvement.
Experience & Skills Required
- Required - High School Diploma/GED: Preferred - Associate's Degree
- Two years of experience in the pharmaceutical industry and knowledge of cGMP is necessary.
- Experience in the areas of production, packaging, or validation or equivalent education in a science-related discipline is required