Manufacturing Quality Support Senior Associate

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
The Manufacturing Quality Support Senior Associate provides Quality Assurance (QA) support to clinical, commercial, and contract manufacturing operations. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices).The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site.
How You Will Achieve It

• Perform manufacturing Quality support activities to include at minimum work order approvals, Board of Health Sample Management, Quality System Master Data Approval, and Manufacturing area QA release
• Identify deviations from established standards; monitor and perform housekeeping and GMP walkthroughs of the facility
• Provide manufacturing shop floor support
• Participate in internal Good Manufacturing Practices audits and support regulatory inspections or corporate audits
• 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
• Provide Quality review and oversight of cGXP documentation related to the operation of a manufacturing facility to ensure compliance with global regulatory agencies and Pfizer Quality standards
• Perform Annual Product Records Authoring and Review (APRR)
• Assist with other tasks as needed such as: Complaint Investigation Review / Approval, Internal Audits / Assessments, regulatory inspection response coordination, Gap Analysis, Alert reports, Quarantine Alerts, Adverse Events, and Biological Product Deviation Reports
• Investigate and document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance lead in a timely manner
• Provide guidance / coaching to less experienced QA and Manufacturing colleagues
• Work cross-functionally with various business groups (i.e., Operations, Tech Ops, Automation, Compliance, Process Engineering, Investigators, etc.)
• Represent QA in cross-departmental / cross-site meetings. Independently makes decisions with minimal assistance from QA management
• Facilitate, author, and approve risk assessments

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.
• 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

• Knowledge of electronic systems including Trackwise, Veeva Vault, Documentum / PDOCs, SAP, gLIMS, Microsoft Office

PHYSICAL/MENTAL REQUIREMENTS

• Requires working on the shop floor and in an office setting
• Computer usage would be typical
• Must have the ability to stand for 2-3 hours at a time, sit for 2-3 hours at a time, aseptically gown into manufacturing areas, and walk long distances

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work schedule is primarily first shift during weekdays, but may include weekends and second, and / or third shift hours to support manufacturing operations activities
• Ability to adhere to safe work practices and procedures such as aseptic gowning
• Limited travel for the position; no more than 5% traveling

Other Job Details:

• Relocation supports available
• Last day to Apply: January 23, 2025
• 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 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