Job Title: QA Operations Specialist
Overview:
Pfizer's commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first.
Key Responsibilities:
* Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
* Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
* Approve investigations and change control activities to maintain compliance with configuration management policies.
* Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
* Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
* Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
* Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Requirements:
* High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
* Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
* Strong critical thinking skills
* Ability to work effectively within own team and interdepartmental teams
* Good working knowledge of Microsoft Excel and Word
* Proactive approach to problem-solving