QA Technician I (3rd shift) (Sun 10p-Fri 6 : 30a)

QA Technician I

Job Summary :

The Quality Technician supports manufacturing and packaging for quality related incidents and ongoing cGMP compliance.

Quality Technicians are required to make decisions regarding product quality in order to isolate, segregate, and correct potential impact to manufacturing and packaging in a timely manner in order to prevent loss of product integrity and operations downtime.

The Quality Technician I is the entry level Quality Technician position.

Responsibilities :

• Make disposition of materials affected by quality incidents such as OOS in-process results, foreign materials, spills, equipment failure etc. with Quality management oversight.
• Isolation and evaluation of adulterated products.
• Determine next course of action for continuation of production with Quality management oversight.
• Communicate and document actions taken.
• Directing Operations floor management on course of actions for quality events with Quality a higher degree of management oversight.
• Requires interaction with management on some routine events.
• Review live batch records for completeness and compliance.
• Audit of the facility for ongoing cGMP compliance.
• In the absence of a supervisor and / or Team Lead, assume the responsibility for operational decisions.
• Release equipment for use.
• Verify cleanliness of equipment.
• Issue supplemental cGMP documentation.
• Training personnel for inspection activities.
• Issuance and management of 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.

Education / Qualifications :