Quality Associate, Operations

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:

• Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness.
• Conduct on-the-floor QA review of executed batch records and other manufacturing documentation to ensure adherence to site procedures, regulatory standards and filing requirements.
• Provide triage support across departments to address quality issues, ensuring timely escalation to management when necessary.
• Review and approve deviations, including the associated investigation reports, and corrective/preventative actions.
• Author, review and approve SOPs as appropriate for both Operations and Quality.
• Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities.
• Participate in internal audits, support regulatory inspections or corporate audit activities, as needed.
  Here Is What You Need (Minimum Requirements)
• 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
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
• Effective written and oral communication skills
  Bonus Points If You Have (Preferred Requirements)
• Experience at a manufacturing site.
• Managing and writing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
  PHYSICAL/MENTAL REQUIREMENTS
• 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 colleagues, and management to gather the input and background knowledge needed to complete assignments.
• Must be able to gown for entering controlled areas.
• Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.).
  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• This role is primarily a Wednesday - Saturday schedule (4/10s), with 24/7 support of manufacturing as quality issues arise (10 am - 8 pm)
  Work Location Assignment: On Premise

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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 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 www.pfizer.com/careers accessible 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 [email protected] . 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.
Quality Assurance and Control