Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Role Summary: The Gene Therapy Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to Gene Therapy clinical, commercial, and contract manufacturing operations with QA Operations Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include, but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, and review/approval of new/existing procedures (SOPs, MBRs, Job Aid’s, etc.). The Senior Associate will work cross-functionally with manufacturing support groups to investigate manufacturing events, perform compound/intermediate and final product disposition, and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site and provides on-call, after hours and weekend support to ensure no interruptions of 24/7 operation.

Key Roles and Responsibilities:

• Provide Quality Assurance floor oversight to Manufacturing. This position is a 12-hour shift (7:00PM – 7:00AM) for coverage Sunday - Wednesday. The Manufacturing Quality Operations Senior Associate support includes documentation review, facility walkthrough, remediation/escalation of non-conformances, deviations, and other issues from the manufacturing floor including support for drug substance/drug product related processes (i.e., review of in-process records, AQL, aseptic observation, smoke studies, etc.)
• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS) expectations.
• Work cross-functionally with various business groups (i.e., Operations, Tech Ops, Automation, Compliance, Process Engineering, Investigators, etc.) on manufacturing deviation events to identify root cause(s), complete impact assessment, and identify Corrective/Preventive Action (CAPA).
• Represent QA in cross-departmental/cross-site meetings. Aid in resolving and provide guidance/path-forward. Independently makes decisions with minimal assistance from QA management.
• Participate/lead manufacturing area(s) shutdown activities.
• Support site regulatory inspections.
• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.
• Lead & suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the “one best way” philosophy.
• Perform intermediate, compound, and final product disposition using computer software applications including, but not limited to: gLIMS, SAP, MES, AMPS, Batch Tracker.
• Review/approve new/existing procedures ( SOPs, MBRs, Job Aids, etc.) in Documentum/ PDOCS to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.
• Perform Annual Product Records Review (APRR) of drug substance intermediates, drug substances, and drug product.
• Assist with other tasks as needed such as: Complaint Investigation Review/Approval, Internal Audits/Assessments, FDA response coordination, Gap Analysis, Regulatory Inspection Readiness. Provide guidance/coaching to less experienced QA and Manufacturing colleagues.

This Job Description indicates the general nature and level of work expected of the incumbent.

It is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the colleague. Colleagues may be asked to perform other duties, as required.

Qualifications

Must-Have

• High School Diploma (or Equivalent) and 8 years of relevant experience; OR an Associate's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with 6 years of experience OR; a Bachelor's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with at least 3 years of experience; OR a Master's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with more than 1 year of experience.
• Experience in Quality administered systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills
• Good working knowledge of Microsoft Excel and Word

Nice-to-Have

• Master's degree and relevant pharmaceutical experience
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

PHYSICAL/MENTAL REQUIREMENTS

Technical Competencies:

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.
• Knowledge of, and experience in a biopharmaceutical/pharmaceutical cGMP environment.
• Knowledge of electronic systems including Trackwise, Documentum/PDOCs, SAP, gLIMS, Microsoft Office.
• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements.
• Collaboration skills and the ability to independently engage with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments.

Behavioral Competencies:

• Effective written and verbal communication skills coupled with interpersonal skills and the ability to establish relationships within the company.
• Strong attention to detail.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable timeline is at risk.
• Ability to positively receive feedback from management and colleagues.
• Takes accountability for actions and personal development.
• Ability to organize work tasks and adhere to assigned work to meet deadlines and departmental goals.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to work 12-hour shift Sunday - Wednesday
• Must be able to adhere to aseptic gowning requirements
• Must be able to adhere to safe work practices
• This position is a 12-hour shift (7:00PM – 7:00AM) for coverage Sunday - Wednesday.

Relocation support available
Work Location Assignment:On Premise

Last day to apply: Monday, November 11th, 2024

The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control

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