QC Technical Data Reviewer
PfizerAbout the role
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.
Role 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.
Here Is What You Need (Minimum Requirements)
Applicant must have HS Diploma or GED and 10 years of relevant experience; OR an Associate’s degree with 8 years of experience; OR a Bachelor's degree (preferably in Chemistry or other related Science) with 6 years of experience
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
Bonus Points If You Have (Preferred Requirements):
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
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