Quality Assurance Specialist

Quality Assurance Specialist

Location: Indianapolis, IN

Pay: Starting at $65,000

Job Type: Full-Time

The Company:

A leading global pharmaceutical organization dedicated to delivering innovative products that enhance patient outcomes. With a strong commitment to regulatory compliance, operational excellence, and scientific innovation, this company fosters a supportive and growth-driven environment. Their focus on safety, quality, and continuous learning drives their success and ability to positively impact the healthcare industry.

The Team:

Be part of a talented team of professionals focused on maintaining the highest standards of quality assurance across global systems. As a key member, you will collaborate with experts in compliance, system validation, and quality management. This team thrives on collaboration, shared success, and continuous improvement, where your contributions will make a meaningful difference.

What You'll Be Doing:

• Oversee and manage quality assurance activities related to global computer systems and applications, ensuring documentation for observations, deviations, and compliance initiatives is complete and accurate.
• Ensure that all systems comply with regulatory requirements and provide quality approval for documents supporting regulatory submissions and new product initiatives.
• Collaborate with cross-functional teams to enhance the operational efficiency of both local and global business processes.
• Review, approve, and ensure the integrity of validation documents, risk assessments, change controls, and system protocols for global systems and laboratory applications.
• Ensure system validation protocols, method validations, and business continuity plans comply with regulatory standards and best practices.
• Support User Acceptance Testing (UAT) and ensure system enhancements align with regulatory commitments and compliance standards.
• Evaluate and prioritize risks for global computer systems and applications in collaboration with system owners and key stakeholders.

The Skills You Will Need:

• Bachelor’s or Master’s degree in Chemistry, Biology, or a related scientific discipline.
• A minimum of 3 years of experience in the pharmaceutical industry with a focus on quality assurance and regulatory compliance.
• Deep knowledge of regulatory standards (e.g., cGMP), quality management systems, data integrity, and system validation processes.
• Proven experience in overseeing system validations, analytical investigations, and control measures for global computer systems.
• Strong familiarity with laboratory operations, particularly Quality Control labs and the product lifecycle from development through commercialization.
• Excellent problem-solving skills with the ability to provide customized solutions based on customer and regulatory needs.
• Strong communication and collaboration skills, with a demonstrated ability to work effectively across teams and stakeholders.

What It Offers:

• Career Growth: Build your expertise in quality assurance and system validation within a global pharmaceutical environment, with numerous opportunities for career advancement.
• Impactful Work: Play a key role in ensuring the compliance and integrity of global computer systems that support regulatory submissions and new product initiatives.
• Collaborative Culture: Work in a team-oriented environment where knowledge sharing, innovation, and personal development are highly encouraged.

Ready to take the next step in your career?

• Apply today to join a leading global pharmaceutical organization that values quality, compliance, and innovation. Submit your resume now—video interviews are being scheduled, so don’t miss out on this exciting opportunity!