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Epic Cadence Consultant
Cuyahoga Falls, OH
$21-23/HR
Quality Technician assures compliance to the packaging quality systems related to incoming packaging while actively investigating system and component deviations or issues.
Quality Technician Responsibilities
- Provides support for any function relating to quarantined items NCE and CAPA QNs, and current Good Manufacturing Practices (cGMP) compliance
- Responsible for the processing of both previous and newly generated Quality Notifications (QNs)
- Responsible for analyzing the impact of rejections and the blocking of material outside the initial QN
- Works with Global Sourcing on QN assignment, complaint investigations and sample requests
- Provides leadership for and coordinates the disposition (release, return, rework or scrap) of quarantined materials
- Works with suppliers to resolve out of specification situations
- Monitors and audits the disposition process; may support GQMI staff on small reworks
- Reviews, approves, and may author or help author procedures, work instructions, and rework instructions.
- Ensures the receipt of Root Cause Analysis (RCA) & Corrective Action; Preventative Action (CAPA) from Vendors on appropriate QN Levels
- Engage appropriate GOJO technical resources (PEC, Packaging Engineering, Others) to evaluate RCA / CAPA
- Evaluate specifications against production QNs and engage appropriate GOJO technical resources
- Provides QN reporting
- Perform physical inspection of materials against predefined criteria/specifications as needed
Quality Technician Qualifications:
- Bachelor’s in a technical field highly preferred with two (2) to five (5) years Quality or Regulatory experience in a cGMP environment.
- Combination of education and experience will be considered
- Prior experience in quality, regulatory and/or regulated manufacturing environment highly preferred
- Moderate to advanced computer skills and experience with word processing, spreadsheets, and databases.
- Demonstrated job record of success and increasing responsibilities.