QC Technical Data Reviewer

Pfizer • Rocky Mount, NC

2d • $32 - $53 • Onsite

About The Position

Use Your Power for Purpose 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 analysis through research programs, your contribution directly impacts patients. As a member of the Global Supply division, you will play a crucial role in improving patients' lives while working at Pfizer. Your expertise in quality assurance will ensure that our products meet the highest standards, ultimately benefiting those who rely on our medications. What You Will Achieve Serve as a key resource and potentially lead lower levels within your area of expertise. Manage personal time, professional development, and workflow, while possibly leading and allocating work to others. Contribute to project and departmental tasks, providing direction, training, and potentially acting as a lead worker. Be recognized as a "LEAD" or "Subject Matter Expert" and proactively identify and resolve basic complexity problems. Complete assignments independently, ensuring team assignments are completed, and review non-standard work for technical soundness. Adhere to Pfizer standards, guidelines, and values, influencing teams, and training others while ensuring quality in clinical and commercial drug batches. Evaluate and review batch records, manage batch disposition, and maintain documentation, utilizing sampling and statistical process control skills. Review and approve investigations and change control activities, adapting standard methods and procedures based on expertise and experience. Train others, support equipment calibration and maintenance, and assist in investigating deviations to aid in corrective actions. Perform and document qualitative or quantitative assays, review sterility and potency assays, maintain records, and oversee quality operations in a fast-paced laboratory environment.

Requirements

• Applicant must have 10 years of relevant experience; OR an Associate’s degree with 8 years’ experience; OR a BS/MS in Chemistry or Science Degree, at least 6 years analytical laboratory experience in a GMP regulated environment; OR 4 years for MS/PhD
• Experience in parenteral drug product pharmaceutical manufacturing is plus.
• Successful hands-on analytical testing experience in aGMP environment.
• Must have experience training and/or mentoring junior staff
• Certifications in the assigned area if applicable
• Successful hands-on analytical testing experience in a Good Manufacturing Practices (also cGMP) environment
• Demonstrated proficiency in applicable computer software and systems
• Personal leadership and accountability in day-to-day interactions
• Operational regard for customer needs and process requirements
• Strong organizational skills and the ability to multi-task across projects and activities
• Good communication skills for written reports and basic computer skills in Microsoft Office

Nice To Haves

• Bachelor's Degree
• Experience in quality functions of the pharmaceuticals industry
• Proficiency in using the Quality Tracking System, Laboratory Information Management System, Application & Products, and Lot Review Tracking systems
• Excellent attention to detail and accuracy
• Strong interpersonal skills and the ability to communicate effectively with team members and stakeholders
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

Responsibilities

• Functions as dedicated data reviewer for QC Chemistry laboratories.
• Reviews testing documentation, electronic data and associated audit trails.
• As needed, performs data entry and calculation corrections.
• Attains qualified trainer status to train others.
• Provide support to ensure lab safety and compliance: through safe use of chemicals and/or the recognition of DEA, FDA, OSHA and ICH guidelines.

Benefits

• 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: Mid Level