Quality Assurance Sr. Associate

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

In this role, you will:

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) .
• Identify and implement new processes and programs for quality improvement.
• Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
• Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Pfizer standards, policies and values in a timely manner.
• Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
• Analyzing data to identify trends, patterns, and opportunities for improvement. 
• Identify and solve business problems to improve efficiency and productivity. 

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at +2 years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience.
• Understanding of current Good Manufacturing Practices and relevant GxP regulations and standards used in the Industry.
• Good working knowledge of Microsoft 365 -Excel and Word
• Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems
• Experience with programming Python, SQL, NumPy, Mixpanel and Java.
• Ability to evaluate loads of information and extract data.

  
Physical/Mental Requirements

• Strong organizational skills, attention to detail and able to manage different priorities

• Ability to work effectively within own team and interdepartmental teams

• Strong critical thinking skills

• Able to sit and review documentation for long periods of time

Non-Standard Work Schedule, Travel, or Environment Requirements

• This role is standard day Monday through Friday work shift.

Other Job Details:

• Last day to Apply: April 15th, 2025
• Eligible for Relocation Assistance: No
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $80 300,00 to $133 900,00. 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.

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