Senior QA Validation Associate
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Job Location:
Sanford, FL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
Every day Pfizers 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:
Review validation documentation for the site (including but not limited to change controls cleaning process equipment laboratory validation data records SOPs automationand maintenance document and technical reports associated with clinical and commercial processing) ensuring adherence to regulatory agency requirements ICH Guidelines and Pfizer standards policies and values
Plan and execute projects with support; suggest improvements and conducts continuous improvement activities
Represent QA Validation in cross-departmental/cross-site meetings
Maintain oversight of quality and compliance requirements throughout the product life cycle from design through BLA submission
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Evaluate review and approve validation master plans protocols and reports ensuring compliance with company standards and regulatory requirements.
Troubleshoot validation issues for equipment and performance processes providing expertise for resolution.
Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
Support product transfers new product development regulatory queries cost improvement projects and Cleaning Validation ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
Applicant must have a Bachelors degree with at least 2 years of experience; OR a Masters degree with 0 years of experience; or an Associates degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience.
Proven expertise in current Good Manufacturing Practices and relevant GxP regulations and standards.
Experience with regulatory compliance and documentation
Familiarity with information systems such as Global Document Management System System Application & Products and Quality Tracking System
Strong working knowledge in Microsoft Office Suite
Bonus Points If You Have (Preferred Requirements)
Strong technical knowledge with validation/qualification of pharmaceutical processes equipment utilities facilities and/or computer systems
Experience in regulatory audits and compliance
Experience with sterile products and medical devices
Physical/Mental Requirements
Excellent verbal and written communication skills
Ability to work independently and in a team environment
Strong analytical and problem-solving skills
Strong organizational and time management skills
Ability to mentor and guide other colleagues
Non-Standard Work Schedule Travel or Environment Requirements
This role is standard day Monday through Fridaywork shift.
Other Job Details:
Last day to Apply: October 13th 2025
Eligible for Relocation Assistance: No
Work Location Assignment:On Premise
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Senior IC
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
