Senior Quality Specialist

Par Health; Rochester (MI); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Par Health, Inc. seeks a Senior Quality Specialist to review batch records and COAs, determine release readiness, and ensure timely quality holds when needed.

The role partners across departments to address errors, drives CAPA actions, and supports continuous improvement initiatives in a regulated manufacturing environment. Key responsibilities include on-the-floor MQAs, defect characterization, and collaboration with QA, manufacturing, and packaging teams.

Qualifications

• Bachelor's degree in a scientific, technical, engineering, quality, or related discipline.
• Minimum 7 years of experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Experience in Quality Assurance, Manufacturing QA, QC, inspection, or QA systems.
• Working knowledge of cGMP, GDP, FDA regulations and pharma quality systems.

Responsabilités

• Review batch records, production docs, and quality records for accuracy and compliance.
• Lead or participate in investigations, CAPAs, deviations, and change controls.
• Perform on-the-floor MQAs including line clearances, inspections, and material releases.
• Evaluate defects (visible particulates, cosmetic defects, closures) and classify as Critical/Major/Minor.
• Provide training and coaching on defect recognition and quality practices.

Connaissances

Quality Assurance

cGMP knowledge

Problem solving

Analytical thinking

Cross-functional collaboration

Technical writing

Training and coaching

Attention to detail

Decision making

Organizational skills

Formation

Bachelor's degree in a scientific discipline

Outils

ERP systems

Microsoft Office

Quality management systems

Description du poste

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.

The Senior Quality Specialist reviews all pertinent records, including Batch Records and laboratory Certificates of Analysis to confirm accuracy, and makes the determination of acceptability for product release. In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, assesses compliance risk, decides when to elevate to supervision, and takes action to place lots on Quality Hold as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner. Compiles timely and accurate data for business metrics, analyzes and summarizes for Quality Management Review Index. Leads or participates on cross-functional teams for continuous improvements. May participate in “on the floor” Quality activities during product manufacturing.

Job Description

Key Responsibilities

• Batch Record & Production Review
• Perform Manufacturing Quality Assurance (MQA) activities on the manufacturing floor, including line clearances, room and equipment inspections, cleaning verifications, and material releases.
• Review batch records, production documentation, logbooks, and supporting quality records for accuracy, completeness, and compliance.
• Reconcile documentation discrepancies and support timely resolution of production and quality issues.
• Execute product release, quarantine, segregation, and hold activities within applicable quality and ERP systems.
• Support internal audits, GMP walkthroughs, quality inspections, and regulatory audit readiness activities.
• Escalate quality concerns and potential product-impacting issues to management as appropriate.
• Defect Characterization & Product Quality Assessment
• Evaluate, characterize, and classify defects identified during incoming, in-process, finished product, retain, and investigation sample inspections.
• Classify defects according to established quality standards as Critical, Major, or Minor and document supporting rationale.
• Perform defect sub-classification activities to support investigations, trend analysis, and continuous improvement efforts.
• Assess visible particulates, cosmetic defects, container closure concerns, and other product quality observations for potential product impact.
• Collaborate with Visual Inspection, Packaging, Manufacturing, and Quality teams to evaluate inspection findings and support product quality decisions.
• Maintain accurate defect characterization documentation in accordance with cGMP and internal procedural requirements.
• Support development and maintenance of defect libraries, inspection standards, and characterization guides.
• Quality Management Systems & Continuous Improvement
• Initiate, complete, and support quality system records including deviations, investigations, change controls, holds, CAPAs, and document revisions.
• Lead or participate in investigations related to product defects, quality events, inspection findings, and manufacturing deviations.
• Apply quality risk assessment principles and scientific judgment to support investigation outcomes and product impact assessments.
• Recommend and implement corrective and preventive actions (CAPAs) to address recurring quality issues.
• Review and update Quality procedures and standard operating procedures (SOPs).
• Identify opportunities for process improvements and support implementation of quality and operational excellence initiatives.
• Participate in process validation, equipment qualification, and continuous improvement projects as a Quality representative.
• Training & Technical Support
• Serve as a qualified trainer for quality systems, procedures, and inspection-related activities.
• Provide coaching and technical guidance regarding defect recognition, classification, and quality assessment practices.
• Support development of inspection personnel through training and knowledge sharing.
• Compliance & Quality Culture
• Ensure compliance with cGMP, GDP, FDA, USP, DEA, and company quality requirements.
• Support customer, internal, and regulatory audits and inspections.
• Promote a culture of quality, compliance, safety, and continuous improvement.
• Communicate quality metrics, trends, and significant events to stakeholders and operational teams.

Education & Experience

• Bachelor's degree in a scientific, technical, engineering, quality, or related discipline.
• Minimum of 7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience in Quality Assurance, Manufacturing Quality Assurance, Quality Control, Inspection, or Quality Systems functions.
• Knowledge
• Working knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems.
• Knowledge of sterile manufacturing processes and aseptic operations.
• Knowledge of visual inspection processes, defect characterization methodologies, and defect classification standards.
• Familiarity with USP and regulatory guidance related to visual inspection, visible particulates, and product quality evaluation.
• Knowledge of investigation practices, root cause analysis, CAPA development, and quality risk assessment.
• Proficiency with quality management systems, ERP systems, and Microsoft Office applications.
• Critical Thinking
• Analytical Problem Solving
• Scientific Judgment
• Quality Risk Assessment
• Investigation and Root Cause Analysis
• Technical Writing and Documentation
• Attention to Detail
• Decision Making
• Technical Communication
• Training and Coaching
• Cross-Functional Collaboration
• Organization and Prioritization Skills
• Preferred Qualifications
• Experience in sterile injectable pharmaceutical manufacturing.
• Experience with defect characterization, visible particulate identification, and visual inspection processes.
• Experience supporting product-impact assessments and defect-related investigations.
• Qualification or prior experience in visual inspection activities.
• Experience supporting regulatory inspections and customer audits.