Quality Associate Specialist, Defect Characterization

Job description

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day. Job Description Summary Company We’re Par Health, the essential pharmaceutical company, making quality generic medicines people can count on—leading with excellence and committed to those we serve. With 4,000 team members worldwide, our reputation is built on reliability, compliance, and service—because patients depend on it. With approximately 80 product families, our broad product portfolio spans multiple therapeutic areas, dosage forms and delivery technologies, including oral solids, liquids, sprays, patches, and more designed to meet the needs of patients and healthcare providers. From everyday medicines to specialized care, we’re here to advance better health. Summary of Position 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. Job Description Responsibilities 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. Minimum Requirements Associate degree in a scientific, technical, or quality-related discipline, or equivalent combination of education and experience. Preferred Experience within 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. Key Competencies Critical Thinking Analytical Problem Solving Quality Risk Assessment Attention to Detail Scientific Judgment Decision Making Investigation Skills Technical Communication Regulatory Compliance Continuous Improvement Mindset Relationship with Others/Scope of Position 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. DISCLAIMER: 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. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.