Quality Associate Specialist, Defect Characterization in Utica, Michigan

Quality Defect Characterization Associate Specialist

The Quality Defect Characterization Associate Specialist is responsible for the evaluation, classification, and characterization of product defects identified during visual inspection activities within a sterile injectable manufacturing environment. This role serves as a technical quality resource, applying critical thinking and sound scientific judgment to determine defect classifications, assess product quality impact, and support quality decision-making processes.

• Evaluate and characterize defects identified during incoming, in-process, finished product, and retain sample inspections.
• Classify defects according to established quality standards and regulatory guidance as:
• Critical Defects
• Major Defects
• Minor Defects
• Provide technical justification and documented rationale supporting defect classifications.
• Sub-classify defects as necessary to support trend analysis, investigations, and continuous improvement activities.
• Perform particulate identification and characterization activities, including assessment of product-contact and non-product-contact particles.
• Support investigations involving visible particulate contamination, cosmetic defects, container closure concerns, and other product quality observations.
• Apply critical thinking and scientific judgment to determine potential product impact and recommend appropriate actions.
• Defend and communicate quality decisions to cross-functional stakeholders during investigations and quality reviews.
• Collaborate with Incoming Inspection and Retain Inspection personnel to evaluate inspection findings and establish defect trends.
• Support development and refinement of defect libraries, inspection standards, and characterization guides.
• Assist in training and mentoring inspection personnel on defect recognition and classification.
• Partner with Manufacturing Quality Assurance (MQA), Quality Control, Operations, and Technical Services to resolve defect-related issues.
• Maintain accurate documentation in accordance with cGMP requirements and internal quality procedures.

• Associate degree in a scientific, technical, or quality-related discipline, or equivalent combination of education and experience.

• Experience with in sterile injectable manufacturing Experience in a pharmaceutical, biotechnology, medical device, or sterile manufacturing environment.
• Experience with visible particulate inspection and particle identification.
• Knowledge of USP, FDA, and global regulatory guidance related to visual inspection and defect classification.
• Experience supporting investigations, root cause analysis, and quality systems.
• Familiarity with Visual Inspection Technician (VIT) and Manufacturing Quality Assurance (MQA) processes.

• Critical Thinking
• Analytical Problem Solving
• Quality Risk Assessment
• Attention to Detail
• Scientific Judgment
• Decision Making
• Investigation Skills
• Technical Communication
• Regulatory Compliance
• Continuous Improvement Mindset

• Successful qualification and maintenance of qualification in visual inspection are conditions of employment. Failure to obtain or maintain required visual inspection qualification may impact continued employment in this role.
• This position works closely with Packaging, Inspection, Manufacturing Quality Assurance (MQA), Quality Control, and other Quality team members to evaluate and characterize product defects identified throughout the inspection process.
• The incumbent is expected to collaborate effectively with cross-functional stakeholders, provide technical guidance on defect classification, and support quality-related investigations and decision-making activities.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.