Associate, Oncology Operations

Role Summary

Associate, Oncology Operations

Responsibilities

• Execute production activities using knowledge of process equipment, systems, and manufacturing operations.
• Participate in operational qualification training and assist the Team Lead as needed.
• Ensure all activities comply with Company policies, standard operating procedures, Pfizer Values, and global regulatory and environmental guidelines.
• Work in a structured environment using established procedures.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy.
• Assist in troubleshooting, technology transfer, and start-up activities. Applies established analytical tools to reduce cycle times and optimize production scheduling.
• Oversee technical documentation for production and process approvals, ensuring compliance with Current Good Manufacturing Practices, and manage process activities by adhering to Standard Operating Procedures.
• Assists production teams with batch paperwork and performs system transactions.
• Monitors and communicates production metrics.
• Ensures compliance with all government and company regulatory requirements.
• Verifies batch reconciliation and investigates all discrepancies immediately. Prepares Manufacturing Discrepancy Reports, as necessary, and escalates issues requiring Management Investigation Reports (MIRs) regarding deviations in process tasks or equipment set-up and testing. Partners with the Quality, Technology and Operations personnel to investigate Manufacturing Incidents applying tools as CAPA to eliminate root cause in investigating.
• Participates in continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time.
• Able to handle routine problems independently. Works with cross-functional experts in solving problems.
• Reviews, updates, and revises SOP's.

Qualifications

• Required: Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Knowledge of process equipment and manufacturing operations
• Ability to follow standard operating procedures and regulatory guidelines
• Basic understanding of Current Good Manufacturing Practices
• Strong organizational skills to manage project tasks and meet deadlines
• Technical documentation skills for production and process approvals

Bonus Points If You Have

• Experience within the pharmaceutical industry
• Familiarity with Six Sigma or other operational excellence programs
• Proficiency in troubleshooting and technology transfer activities
• Strong analytical skills for process monitoring and data analysis
• Excellent communication skills for presenting data in project team meetings
• Strong problem-solving skills

Physical

• Ability to gown aseptically, stand for long periods of time, to lift 50 lbs.

Additional Requirements

• Ability to shift work schedule to accommodate production needs. Occasional evening or weekend work.
• Work Location Assignment: On Premise colleagues work in a Pfizer site because it‚Äôs needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.