Senior Quality Assurance Specialist

AstraZeneca; Vernon (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Quality Assurance Specialist to ensure compliance and quality in innovative medicine production. This role involves leading inspections, managing compliance programs, and overseeing quality systems to uphold GMP standards. With a focus on continuous improvement, you'll collaborate with multidisciplinary teams and influence stakeholders to drive excellence. If you're passionate about quality and ready to make a significant impact in a dynamic environment, this opportunity is perfect for you. Join a company dedicated to growth and innovation in the pharmaceutical sector.

Qualifications

• 5+ years in industry or FDA experience, with 3+ years in QA/Compliance.
• Knowledge of global regulations and cGMP is essential.

Responsibilities

• Drive compliance and quality excellence in processes.
• Lead inspections and manage quality systems.

Skills

Compliance Expertise

Quality Assurance

Communication Skills

Project Management

Technical Writing

Interpersonal Skills

Education

Bachelor’s in Science

Bachelor’s in Pharmacy

Bachelor’s in Biology

Bachelor’s in Chemistry

Bachelor’s in Engineering

Tools

Quality Management Systems

CAPA

SOPs

Job description

Join to apply for the Senior Quality Assurance Specialist role at AstraZeneca

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life-changing oral solid medicines. The site formulates and packs OSD tablets and capsules for over 60 markets. It is the largest AZ production site in the US with over 700 employees, located in Indiana near Evansville. The site promotes diversity, inclusion, and professional development through employee resource groups.

Are you ready to lead in ensuring compliance and quality? As a Senior Quality Assurance Specialist, you'll drive excellence in our processes, manage compliance programs, oversee quality systems, and influence stakeholders. Your role involves leading inspections, continuous improvement, and ensuring GMP standards are met.

Accountabilities:

Compliance Leadership

• Serve as primary contact for regulatory communications.
• Lead inspection preparations, management, and responses.
• Collaborate to improve compliance programs.
• Provide compliance expertise and identify gaps.
• Act as SME on issues management and resolution.
• Participate in quality reviews and forums.
• Design and deliver GMP training.
• Review SOPs, investigations, CAPA.
• Lead or participate in compliance and quality projects.
• Implement regulatory revisions.
• Support validation, qualification, and change control activities.

Quality Systems Ownership

• Manage core quality systems (e.g., complaints, change control, deviations, CAPA, audits).
• Maintain quality system procedures.
• Manage system access and permissions.
• Coordinate with other sites for standardization.
• Analyze data, publish trend reports, and support regulatory documentation.

Essential Skills/Experience:

• Bachelor’s in a science-based field.
• Excellent communication skills.
• Strong learning motivation.
• Ability to work in multidisciplinary teams.
• 5+ years in industry or FDA experience, with 3+ years in QA/Compliance.
• Knowledge of global regulations and cGMP.
• Familiarity with production operations.
• Leadership, project management, technical writing skills.
• Interpersonal and influencing skills.

Desirable Skills/Experience:

• Bachelor’s in Pharmacy, Biology, Chemistry, or Engineering.
• 7+ years QA/Regulatory experience.
• Experience leading inspections.
• Managing quality systems experience.
• ASQ certifications (CQA, CQE, CQM).
• Membership in trade associations (ISPE, PDA).

At AstraZeneca, we focus on quality, growth, and innovation, providing opportunities for a fulfilling career. Join us in our mission to deliver medicines safely and reliably.

Ready to advance your career? Apply now and join our journey!