Principal Quality Scientist
Principal Quality Scientist — Seattle, WA
We are seeking a Principal Quality Scientist to provide leadership in the planning and implementation of quality goals and oversee the streamlining of quality policies and procedures for efficiency. The ideal candidate will possess a scientific background to help in the resolution of issues associated to Manufacturing and other critical processes.
The Principal Scientist will take a leadership role in solving extremely complex problems, such as critical Deviations and Change Records, which involve cross-functional teams outside of quality. The Principal will also act as the primary point of contact for critical investigations, ensuring all reports performed are scientifically sound.
Essential Duties and Responsibilities:
- Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with critical deviations.
- Exercises independent judgment in interpreting and applying regulations to GMP systems.
- Makes recommendations for quality policies and procedures, interpreting complex regulations and guidelines critical for advancing and improving quality systems.
- Leads efforts to identify and implement processes and procedure optimization to facilitate compliance.
- Directly involved in the execution and closure of investigations and the implementation of the associated Corrective Actions/Preventive Actions (CAPAs).
- Takes a leadership role in planning and implementation of long-term quality goals as they relate to quality and corporate goals.
- Accountable for decisions and results that promote the efficiency of processes and increase customer satisfaction with internal and external clients.
- Leads projects and represents quality interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression. May act as an advisor to multiple project teams.
- Supports and provides leadership to the direction and decisions of project/transfer teams.
- Responsible for making recommendations and decisions in accordance with federal and international regulatory requirements and industry standards.
- Bachelor's in Biology, Chemistry, Chemical Engineering (or related field) with 10-15 years of Quality experience in biotechnology or pharmaceutical manufacturing environments.
- Strong technical and analytical understanding of Biologics Manufacturing and testing.
- Expert knowledge of Quality and Regulatory principles as they relate to Operations and GMP.
- The ideal candidate should possess scientific background and expertise in areas such as Quality Assurance & Quality Control and be familiarized with the Manufacturing and Development processes (i.e. testing profiles and Laboratory Investigations).
- Experience applying Operational Excellence tools (i.e. Kaizen, Value Stream Mapping, etc.) and basic Risk Management techniques.
- Expert knowledge of GMP and regulatory submission requirements.
- Experience with interpretation and application of regulatory principles which drive quality strategy.
- Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques. Good organizational skills. Demonstrates leadership in areas of teamwork, conflict resolution, and problem-solving
Apply Today! Questions? Call Justin at 714.602.1217 or email your resume to [Click Here to Email Your Resumé]
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.