Quality Control Scientist Jobs

Senior Scientist - Quality Control Analytical

Join our dynamic and rapidly expanding Contract Development and Manufacturing Organization (CDMO) that specializes in biotechnology and pharmaceuticals. We are dedicated to driving advancements in the life sciences industry and are searching for passionate individuals to contribute to our innovative projects. As a vital team member, you will play a pivotal role in shaping the future of biotechnology and pharmaceutical research, development, and manufacturing. If you thrive in a fast-paced and collaborative environment and are committed to making a significant impact on human health, we invite you to embark on this exciting journey with us to create a healthier and brighter tomorrow.

Job Summary:

As the Senior Scientist in Quality Control Analytical, you will be a key contributor to our analytical department, with a focus on overseeing and optimizing activities in the Quality Control Laboratory. Your main tasks will include leading and conducting testing of raw materials, in-process samples, finished products, and stability samples. Additionally, you will play a critical role in conducting instrument validations, cleaning validations, and method qualifications. Your expertise and experience will be vital in communicating project status and handling Out-of-Specification/Out-of-Trend (OOS/OOT) results. Ensuring compliance with Current Good Manufacturing Practices (CGMPs) for analytical test methodologies will be a core aspect of your role.

Job Duties:

• Revise technical documentation as needed to maintain accuracy and compliance, ensuring adherence to industry standards.
• Perform any other duties as required to support the overall success of the organization and advance our scientific capabilities.
• Perform expert peer review of lab work, upholding high-quality standards and providing constructive feedback.
• Mentor and guide junior scientists in the QC Analytical lab, fostering a culture of scientific excellence and growth.
• Manage GMP/ICH compliant stability programs to ensure product quality and reliability.
• Maintain detailed CGMP-compliant documentation to ensure data integrity and accuracy.
• Conduct thorough investigations of Out-of-Specification (OOS) results and customer complaints, applying your expertise to resolve complex issues.
• Execute and lead routine analytical testing using various instruments, applying your deep understanding of analytical techniques.
• Stay updated on regulatory requirements related to analytical testing and quality control and provide guidance on compliance matters.
• Collaborate with cross-functional teams to ensure project timelines are met and provide scientific leadership in analytical methods and techniques.
• Drive continuous improvement initiatives to enhance laboratory processes and efficiency.
• Oversee and participate in cleaning validation studies to maintain equipment and facility cleanliness.
• Contribute to strategic decision-making related to analytical methods and technologies.

Professional Skills:

• Excellent communication skills to effectively interact with team members, stakeholders, and external partners.
• Proficiency in Microsoft Office Suite to facilitate data analysis and reporting.
• Strong planning and organizational skills to lead complex projects and timelines effectively.
• Strong prioritization and decision-making abilities to handle multiple tasks efficiently.
• Bachelor of Science degree in a scientific or technical discipline with extensive relevant experience.

Experience:

• Minimum of 7 years of relevant Analytical Chemistry experience in Quality Control within the pharmaceutical manufacturing industry.

Education:

• Bachelor of Science degree in a scientific or technical discipline; an advanced degree is preferred.

Desired Qualities:

• Strong integrity and a dedication to excellence in all aspects of work.
• Detail-oriented and resilient, with a commitment to maintaining high-quality standards.
• Self-driven and collaborative, able to thrive in a fast-paced and team-oriented environment.

Base Salary: $90,000-$100,000

If you are ready to take on a senior scientific role in an innovative and impactful organization, apply now to join our team and contribute to the advancement of biotechnology and pharmaceuticals. Together, we can make a difference in the world of life sciences and create a brighter future for all.