Quality Compliance Specialist

Responsibilities

• Provide quality oversight in manufacturing areas by enforcing aseptic practices and techniques.
• Conduct GMP walkthroughs to ensure regulatory compliance.
• Provide real-time quality oversight during aseptic process simulations, environmental control deviations, and unplanned activities.
• Oversee daily cleaning and disinfection activities in aseptic and terminally sterilized areas.
• Perform assessments of filling operations and update necessary documentation.
• Conduct audits of sanitation practices, clean room behaviors, and gowning procedures.
• Generate change controls for procedure updates and perform daily room check inspections.
• Support aseptic process simulations, such as media fills, smoke studies, and hyper care for new processes.
• Drive continuous improvement through the implementation of various projects.

Requirements

• Bachelor's degree with 0+ years of experience; OR an Associate's degree with 4 years of experience; OR a high school diploma with 6 years of relevant experience.
• Proven shop floor experience working in an aseptic manufacturing facility.
• Thorough understanding of Good Manufacturing Practices (GMP).
• Practical knowledge and experience in aseptic techniques.
• Proficiency in conducting audits regarding sanitation, aseptic techniques, and gowning.
• Strong oral, written, and interpersonal communication skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.

Preferred Qualifications

• Exceptional leadership and people management abilities.
• Knowledge of the change control process, including document writing and editing.
• Experience presenting sanitation programs to auditors.
• Experience using AI tools (such as ChatGPT or Microsoft Copilot) to support problem-solving and productivity.

About the Company

Pfizer is a global pharmaceutical leader dedicated to delivering breakthroughs that change patients' lives. We rely on a dedicated and agile manufacturing team to bridge the gap between innovation and patient care, ensuring life-saving treatments are accessible to those who need them most.