Principal Quality Specialist

Par Health Enterprises LLC; Rochester (MI); On-site; USD 120,000 - 170,000; Full time

Job summary

Par Health seeks a Principal Quality Specialist, Operations to provide QA oversight in a sterile pharmaceutical manufacturing environment. You will lead defect characterization, risk assessments, and investigations while ensuring compliance with cGMP and regulatory standards across Operations and Quality teams.

You will collaborate with Engineering, Technical Services, and Compliance to drive continuous improvement, manage quality systems, and support investigations and CAPAs in a fast-paced

Qualifications

• Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related technical discipline.
• Minimum of 9 years of experience in pharmaceutical/biotech/regulated manufacturing environments.
• Experience supporting Quality Assurance, Manufacturing Quality Assurance, Quality Systems, or Quality Control activities.

Responsibilities

• Provide quality assurance oversight during manufacturing operations, including inspections, line clearances, and product releases.
• Offer real-time quality guidance to manufacturing personnel and ensure compliance with cGMP, GDP, SOPs and regulatory requirements.
• Review and approve production documentation, batch records, logbooks, and related quality records for completeness and accuracy.
• Evaluate defects and assess potential product impact; classify defects and support investigations and CAPAs.
• Lead or support investigations involving product defects, contaminations, deviations, and regulatory inspections.
• Identify opportunities to improve product quality, inspection processes, and quality systems.

Skills

Quality Assurance

Regulatory Compliance

cGMP

Sterile Manufacturing

Quality Systems

Defect Characterization

Risk Assessment

Investigations

Education

Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related technical discipline

Tools

ERP systems

Microsoft Office

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

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 Principal Quality Specialist, Operations is responsible for providing Quality Assurance oversight and technical leadership within a sterile pharmaceutical manufacturing environment. This role supports Manufacturing Quality Assurance (MQA) activities through on-the-floor quality monitoring, batch record review, quality systems support, and product disposition activities. The position serves as a subject matter expert in defect characterization and quality risk assessment, evaluating product defects, determining potential product impact, and supporting investigations, quality decisions, and continuous improvement initiatives. The Principal Quality Specialist partners closely with Operations, Inspection, Quality Control, Engineering, and Technical Services to ensure compliance with cGMP requirements, regulatory expectations, and internal quality standards.

Job Description Key Responsibilities

Manufacturing Quality Assurance Oversight

• Perform routine quality oversight activities during manufacturing operations, including in-process inspections, line clearances, room releases, cleaning verifications, and product release activities.
• Provide real-time quality guidance to manufacturing personnel and ensure compliance with cGMP, GDP, SOPs, and regulatory requirements.
• Review and approve production documentation, batch records, logbooks, and associated quality records for completeness and accuracy.

Defect Characterization & Product Quality Assessment

• Evaluate, characterize, and classify product defects identified during in-process, finished product, retain, and investigation sample inspections.
• Classify defects as Critical, Major, or Minor in accordance with established quality standards and regulatory requirements.
• Perform defect sub-classification and trending activities to support investigations, risk assessments, and continuous improvement initiatives.
• Assess visible particulates, cosmetic defects, container closure concerns, and other quality observations to determine potential product impact.
• Provide technical justification and documented rationale supporting defect characterization and quality decisions.
• Support development and maintenance of defect libraries, inspection standards, and characterization guides.

Quality Systems & Investigations

• Initiate and support quality system records including deviations, investigations, change controls, holds, CAPAs, and document revisions.
• Lead or support investigations involving product defects, visible particulate contamination, investigation findings, and process non-conformances.
• Apply scientific judgment and quality risk assessment principles to evaluate product impact and recommend appropriate corrective actions.
• Communicate and defend defect classifications, quality assessments, and investigation conclusions to cross-functional stakeholders.

Continuous Improvement

• Identify opportunities to improve product quality, inspection processes, quality systems, and manufacturing operations.
• Analyze defect trends and recurring quality issues to drive sustainable corrective and preventive actions.
• Participate in process improvement, validation, qualification, and operational excellence initiatives.

Minimum Requirements

• Education & Experience: Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or a related technical discipline.
• Minimum of 9 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience supporting Quality Assurance, Manufacturing Quality Assurance, Quality Systems, or Quality Control activities.

Knowledge

• Strong knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems.
• Understanding of sterile manufacturing processes, aseptic practices, and contamination control principles.
• Knowledge of visual inspection principles, defect characterization, defect classification, and quality risk assessment methodologies.
• Familiarity with USP and industry guidance related to visual inspection, visible particulates, and product quality evaluation.
• Proficiency with electronic quality systems, ERP systems, and Microsoft Office applications.

Preferred Qualifications

• Experience in sterile injectable manufacturing.
• Experience with visible particulate inspection, defect characterization, and defect trending.
• Experience supporting deviation investigations, CAPA development, and regulatory inspections.
• Qualification in visual inspection processes or demonstrated experience evaluating product defects within a regulated manufacturing environment.

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.

Come join 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.