Sr. QA Associate

Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:

• Support manufacturing and testing operations conducted at external vendor facilities or at PGS sites on behalf of PSSM through review and approval of manufacturing batch records, API and drug product use periods, and specifications.
• Partner with a Project QA colleague to provide an interface between the project team and other functions within Quality Assurance and Global QO & EHS (e.g. Quality Operations groups supporting internal manufacturing or packaging/labeling, QA Compliance team, QO Center Function, PGS Site QO, External Supply Quality) when needed.
• Interface with colleagues providing QA oversight and support for internal API and DP manufacturing operations to ensure timely release of materials
• Participate as needed in the investigation of product/facility deviations and investigations including root cause analysis, and Pfizer Human Performance assessments
• Use risk-management tools to assess quality issues occurring during manufacturing/testing activities
• Work with PSSM, Global Clinical Supply, PGS and external manufacturing vendors to define and implement CAPA activities for investigations and follow-up trend analysis
• Support PSSM and PGS colleagues in the development of procedures which increase efficiency and maintain high quality standards
• As needed, interface with the PSQA Vendor QA group to ensure that work placed at external vendors is manufactured to the high GMP expectations of Pfizer
• Provide support to internal audits (e.g. RQA) & regulatory inspections (e.g. FDA, MHRA) when required.

• Prepare for and participate in Manufacturing and Supplier Quality Assessment Audits RQA and BOHs Inspections, ensuring successful outcomes and timely implementation/closure of action plans.
• Gather, interpret, and apply statistical methods to various Production/Quality related processes and communicate findings through reports, memos, files, and presentations.
• Implement and adhere to Good Manufacturing Practices regulations and company policies.
• Review area documentation and perform trend analysis on data, controls, and standards.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Strong understanding of Quality System functions, manufacturing and packaging processes, and analytical processes
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software

Bonus Points If You Have (Preferred Requirements)

• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues

Work Location Assignment: Hybrid
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 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.
Quality Assurance and Control