Quality Associate Specialist Defect Characterization
Overview
Lead defect characterization efforts for sterile injectables at Par Health in Detroit. Own end-to-end evaluation of product defects across inspection stages to drive quality decisions. Analyze particulate data and communicate findings to cross-functional teams. Differentiate this role through focus on sterile injectable manufacturing and regulatory compliance.
What You'll Do9
- 1Evaluate and characterize defects from incoming in-process finished product and retain samples
- 2Classify defects using critical major minor categories with documented rationales
- 3Perform particulate identification assessing both product-contact and non-contact particles
- 4Support investigations of cosmetic defects container closure issues and visible contamination
- 5Defend quality decisions through communication with MQA Quality Control Operations and Technical Services
- 6Collaborate with Inspection teams to establish defect trends and refine characterization guides
- 7Maintain accurate cGMP documentation throughout the quality assurance process
- 8Assist in training inspection personnel on defect recognition and classification techniques
- 9Partner with Manufacturing Quality Assurance to resolve defect-related issues
Requirements8
- 1Associate degree in science technical or quality field or equivalent experience
- 2Preferred experience in sterile injectable manufacturing environments
- 3Proven experience with visible particulate inspection and particle identification
- 4Knowledge of USP FDA and global regulatory guidance for visual inspection
- 5Experience supporting investigations root cause analysis and quality systems
- 6Familiarity with Visual Inspection Technician VIT and MQA processes
- 7Strong analytical problem solving and quality risk assessment abilities
- 8Excellent attention to detail and scientific judgment for consistent outcomes
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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