Associate, Oncology Operations

Position Summary

The Associate has accountability for executing assigned tasks and standard work to achieve targets to deliver and improve processes or product consistency, quality/compliance, cost standards and customer service. Ensures that work performed is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Participates in investigations, operates to, and utilizes IMEx process and standards to identify continuous improvement initiatives. Participates in continuous improvement (LEAN and Six Sigma) to improve quality, cost, safety and/or cycle time. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. Has a basic understanding of product cost structure, budgeting process and spend. The goal of the Associate is to efficiently and effectively manufacture product, ensure quality and safety standards are met, and to help improve the business.

Scheduling

• Adheres to production schedule, updates schedule board and communicates daily release schedule. Communicates production information with other shifts.
• Assists production teams with batch paperwork and performs system transactions.
• Applies established analytical tools to reduce cycle times and optimize production scheduling.
• Monitors and communicates production metrics.

Education and Qualifications

Bachelor’s degree in Life Science, Engineering, Business Management or other related technical degree

• BS/BA degree and 0-1 years of relevant experience
• Non-degreed candidates: 3-5 years of relevant pharma or related experience with the approval of the Managing Director and the site HR Director.
• cGMP’s & Safety, Labor relations, review and experience with operations & SOP’s

TECHNICAL SKILLS REQUIREMENTS

Capable of identifying potential system failures and initiating the proper communication or corrective action to avert a system shutdown, which would lead to lost production. Works with teams to solve problems or enhance performance despite obstacles. Requires creativity and innovation while seeking and modifying new designs to improve product flow through the area.

Compliance & Quality

• 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.

COMPETENCIES

Communicating with Impact Can effectively interact with team members. Can articulate the issues and solutions to both the team and to senior management.

Problem Solving Uses rigorous logic and methods to make decisions and solve difficult problems with effective solutions. Can support analytical tools such as LEAN Manufacturing and 6-sigma to improve quality, cost, safety and cycle time.

Planning & Organizing Establishing courses of action for self to ensure that work is completed efficiently.

• Prioritizes—Identifies more critical and less critical activities and assignments; adjusts priorities when appropriate.
• Determines tasks and resources—Determines project/assignment requirements by breaking them down into tasks and identifying types of equipment, materials, and people needed.
• Schedules—Allocates appropriate amounts of time for completing own work; avoids scheduling conflicts; develops timelines and milestones.
• Stays focused—Uses time effectively and prevents irrelevant issues or distractions from interfering with work completion.

Developing Strategic Relationships Uses appropriate interpersonal styles and communication methods to build effective relationships with business partners (e.g., peers, functional partners, external vendors, and alliance partners) to help achieve business goals.

PHYSICAL/MENTAL REQUIREMENTS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to shift work schedule to accommodate production needs. Occasional evening or weekend work.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.