
Quality Specialist
Welcome to PPD-Pharmaceutical Product Development, a global contract research organization dedicated to helping our clients bring life-changing therapies to market. We are currently seeking a highly skilled and motivated Quality Specialist to join our team and contribute to our mission of improving health around the world. In this role, you will play a crucial part in maintaining and continuously improving our quality systems to ensure compliance with regulatory standards and meet the needs of our clients. If you are a detail-oriented and proactive individual with a passion for quality and a background in the pharmaceutical industry, we encourage you to apply for this exciting opportunity. Join us in making a difference in the lives of patients worldwide.
- Collaborate with cross-functional teams to develop and maintain quality systems that meet regulatory requirements and client expectations.
- Conduct internal audits to assess compliance with company policies, procedures, and regulatory standards.
- Identify and communicate potential quality risks and propose solutions to mitigate them.
- Review and approve quality documentation, including standard operating procedures, validation protocols, and reports.
- Monitor and track quality metrics and provide timely reports to management.
- Investigate and resolve quality issues and participate in root cause analysis.
- Conduct training on quality processes and procedures to ensure compliance and understanding across the organization.
- Stay up-to-date with industry trends and regulations related to quality standards and make recommendations for process improvements.
- Coordinate and support external audits and inspections from regulatory agencies and clients.
- Participate in the development and implementation of corrective and preventive action plans to address quality issues.
- Support the implementation of new quality initiatives and continuous improvement projects.
- Act as a subject matter expert on quality-related topics and provide guidance and support to colleagues.
- Foster a culture of quality and compliance throughout the organization.
- Adhere to all company policies and procedures, including safety and confidentiality guidelines.
- Uphold the company's mission and values in all interactions and activities.
Bachelor's Or Master's Degree In A Scientific Field Such As Chemistry, Biology, Or Pharmacy.
At Least 3-5 Years Of Experience In A Quality Assurance Or Quality Control Role In The Pharmaceutical Industry.
Strong Understanding Of Gmp Regulations And Fda Guidelines.
Experience With Conducting Audits And Inspections, As Well As Implementing Corrective And Preventative Actions.
Excellent Communication And Problem-Solving Skills, With The Ability To Work Effectively In A Team Environment.
Quality Assurance
Process Improvement
Data Analysis
Auditing
Quality Control
Root Cause Analysis
Regulatory compliance
Document Review
Gmp (Good Manufacturing Practices)
Sop (Standard Operating Procedures)
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Specialist in Grand Island, NY, USA is between $50,000-$70,000 per year. This may vary depending on factors such as experience, education, and specific job responsibilities. Some companies may offer additional benefits such as bonuses or stock options.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

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