Lead Quality Analyst

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 4,000+ team members worldwide, 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

SUMMARY
The Lead Quality Analyst acts as the team leader for the Quality Associates and Analysts within the Quality Assurance (QA) organization. Serves as the primary for Annual Product Review, customer inquiries, gap assessments, customer audit coordination, and inspection readiness. Additionally, the Lead Quality Analyst serves as back up for quality approval of Exceptions, CAPA, and Change Controls. Key leadership position within the Quality group.

Job Description

ESSENTIAL FUNCTIONS

Provides supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans. Work closely with suppliers to ensure quality expectations and strengthen supplier relationships. Primary point of contact for the Raleigh site for customer inquiries and required documentation for GMP customer requests. Schedule customer audits and coordinate all associated activities, including but not limited to tracking responses and action items to completion. Maintenance of the Site Inspection Readiness Program Leads and participates in Process Improvement teams. Provides technical expertise and guidance to other team members. Evaluates, updates and approves existing SOP’s for cGMP compliance and compliance to corporate procedures. Provide quality training to QA, operational and support personnel as needed.

Oversees and participates in the CAPA process, including writing, review, and monitoring of action items. Participate in Root Cause Analysis teams Reviews and approves investigation reports to ensure they contain the appropriate level of detail and appropriate CAPA’s are identified. Reviews investigations and uses process and equipment knowledge, subject matter expert input, technical documents, and risk management tools to determine potential product impact and product disposition. Works with the appropriate discipline to identify change actions or corrective/preventative measures necessary for improvement and to align processes to consistently manufacture quality products. Programs label changes and add new codes to the labeling computer Provides support to intermediate labeling and tank inspections as needed.

Education:

• Bachelor’s degree in a scientific discipline or technical field related to pharmaceutical manufacturing or equivalent combination of education, experience, and competencies.
• Professional certifications in a Quality Assurance discipline such as CPGP or CQA is preferred.

Experience:

Minimum of 10 years of technical experience in a pharmaceutical manufacturing environment (including QA/QC or engineering experience). Complete knowledge of FDA Code of Federal Regulations (CFR) and International Conference Harmonization (ICH) guidelines, pharmaceutical regulations including current GXP, GLP, or GMP requirements.

Preferred Skills/Qualifications:

• Strong verbal and written communication skills
• Knowledge of Quality Systems
• Knowledge of common Quality Process Improvement techniques
• Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience
• Ability to quickly identify, communicate and/or resolve issues
• Strong communication and leadership skills
• Experience leading training for large groups

Other Skills/Competencies:

• Strong computer literacy—MS office products, statistical analysis (Minitab) and database usage

• Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
• Written Communication: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
• Making Complex Quality Decisions: Can solve even the toughest and most complex of problems; great at gleaning meaning from whatever data is available; is quick study of the new and different; adds personal wisdom and experience to come to the best conclusion and solutions; uses multiple problem-solving tools and techniques.
• Managing Change: Helps employees develop a clear understanding of what they will need to do differently as a result of changes in the organization; establishes structures and processes to plan and manage the orderly implementation of change; helps individuals and groups manage the anxiety associated with significant change; facilitates groups or teams through the problem-solve and creative-thinking processes leading to the development and implementation of new approaches, systems, structures and methods.

Managing Performance: Establishes clear expectations, provides timely, accurate feedback – both positive and negative – and takes appropriate follow-up actions, (for example, rewarding, publicizing successes, coaching and guiding); recognizes, rewards and promotes people based on their performance, achievement of results, and development of competencies; works with individuals to identify areas for development, understand need for improvement, and set specific development goals.

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.