Quality Operations Professional

Pfizer

2d • Onsite

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. What You Will Achieve In this role, you will: Evaluate and review clinical and commercial drug batches to ensure quality. Ensure product and process documents meet established specifications through rigorous sampling and statistical process control. Identify and address deviations from manufacturing and packaging standards. Approve investigations and oversee change control activities to maintain compliance with configuration management policies. Contribute to project tasks and milestones, organizing work to meet deadlines. Learn and apply basic team effectiveness skills within the immediate work team. Make decisions within limited options to resolve basic problems under supervisor's direction. Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards. Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems. Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Requirements

• Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
• Effective written and oral communication skills
• Requires ability to maintain aseptic access
• Strong collaborative/coaching mentality

Nice To Haves

• Experience at a manufacturing site.
• Managing and writing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
• Identify and address deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Learn and apply basic team effectiveness skills within the immediate work team.
• Make decisions within limited options to resolve basic problems under supervisor's direction.
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
• Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.
• Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees