Compliance & Documentation Specialist
Pfizer.com
Office
NC
Full Time
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:
- Evaluate corrective and preventive action responses to audit findings for adequacy and timeliness.
- Ensure Supply Chain policies and procedures are current and comply with Pfizer Quality standards and Regulatory requirements.
- Prepare for and participate in Manufacturing and Supplier Quality Assessment Audits (MSQA) and BOHs Inspections, ensuring successful outcomes and timely implementation/closure of action plans.
- Assist Supply Chain functions with technical issues involving documentation revisions, quality commitments, and audit readiness.
- 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.
- Conduct detailed audit testing in connection with the investigation of allegations of expense report fraud, conflicts of interest, and other violations of Pfizer policies and procedures or laws.
- Review area documentation and perform trend analysis on data, controls, and standards.
- Sponsor, author, and supervise supply chain documentation workflows.
Here Is What You Need (Minimum Requirements)
- Applicant must have a High school diploma (or equivalent) with 8+ years of experience or Associate’s degree with 6+ years of experience or Bachelor's with 2+ years of experience or Master's 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, validations, engineering drawings, and basic statistical processes
- Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
- Experience in preparing and participating in audits and inspections
Bonus Points If You Have (Preferred Requirements)
- Background in handling complaints and utilizing electronic lab systems
- Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
- Experience in mentoring and training colleagues
Physical/Mental Requirements
- Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
- Excellent technical writing, communication, and presentation skills
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Ability to adapt to changing priorities and manage multiple tasks simultaneously
Non-Standard Work Schedule, Travel, or Environment Requirements
- This role is standard office hours, Monday through Friday work schedule
- Last day to Apply: Oct 16th, 2025
- Eligible for Relocation Assistance: No
- Work Location Assignment: Hybrid
- Relocation assistance may be available based on business needs and/or eligibility.
- This role is standard office hours, Monday through Friday work schedule
- Last day to Apply: Oct 16th, 2025
- Eligible for Relocation Assistance: No
- Work Location Assignment: Hybrid
- Relocation assistance may be available based on business needs and/or eligibility.
Other Job Details:
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.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 disabilityrecruitment@pfizer.com. 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 ControlCompliance & Documentation Specialist
Office
NC
Full Time
October 9, 2025