Compliance & Documentation Specialist

Role Summary

The Compliance & Documentation Specialist ensures quality systems compliance and robust documentation within Pfizer's Supply Chain. You will evaluate CAPA responses, participate in audits, and maintain documentation workflows to support quality and regulatory requirements. Strong analytical and communication skills are essential, as is the ability to work collaboratively in a hybrid environment.

Responsibilities

• 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.

Qualifications

• Required: 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
• Required: Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Required: Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
• Required: Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Required: Experience in preparing and participating in audits and inspections
• Preferred: Background in handling complaints and utilizing electronic lab systems
• Preferred: Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Preferred: Experience in mentoring and training colleagues

Skills

• Technical writing, communication, and presentation skills
• Interpersonal communication and collaboration across levels
• Mentoring and training colleagues
• Ability to apply statistical methods and interpret data
• Data-driven decision making and problem solving

Education

• High school diploma or equivalent
• Associate’s degree
• Bachelor's degree
• Master's degree

Additional Requirements

• Schedule: Standard office hours, Monday through Friday
• Work Location: Hybrid