Use Your Power for Purpose

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

As a Senior Associate in Quality Assurance, you will play a pivotal role in supporting laboratory testing for Medical Device and Combination Products (MDCPs) within Pfizer’s Quality Operations. Your primary responsibility will be to oversee and ensure the integrity of laboratory processes related to MDCP components, while reviewing test data and documentation for compliance with regulatory. You will collaborate with product development and sustaining engineering teams to verify that laboratory testing meets stringent safety and effectiveness requirements. Leveraging your expertise, you will proactively address issues, prioritize quality in all laboratory activities, and communicate effectively across teams to drive consensus and support the achievement of quality objectives. Your attention to detail and commitment to quality will be essential in clarifying complex testing matters, assisting with critical deliverables, and fostering a collaborative environment focused on continuous improvement.  Your responsibilities will also involve supporting on-market product change controls.

• Serve as the Quality Assurance lead for laboratory operations related to on-market Medical Device and Combination Products (MDCPs), overseeing the review and approval of all relevant lifecycle documentation, including laboratory test records, change controls, quality management system updates, vendor management files, and complaint reports.

• Ensure that laboratory processes, product documentation, and change management records for medical devices and MDCPs comply with applicable regulatory requirements by providing expert guidance throughout all stages of product lifecycle management, in alignment with 21 CFR 820, ISO 13485, ISO 14971, and related standards.

• Identify, develop, and contribute to the implementation of process improvements and quality initiatives within laboratory operations to drive continuous improvement and regulatory compliance.

• Support and prepare for audits and inspections by regulatory agencies, such as the FDA, notified bodies, competent authorities, and other third parties, ensuring laboratory and change management documentation is complete and inspection-ready.

• Offer guidance and recommendations in the creation and execution of implementation plans for compliance with new regulations, standards, and internal procedures impacting laboratory operations and change control for on-market products.

• Apply expertise in quality investigation techniques to assist in root cause analysis and resolution of deviations related to laboratory testing, design verification, validation, and manufacturing activities for MDCPs.

• Review and approve project documentation associated with laboratory operations and change management, including protocols, validations, non-conformance and complaint records, supplier assessments, and quality agreements.

• Collaborate effectively with cross-functional departments, suppliers, and subject matter experts to achieve laboratory quality objectives and implement quality-driven process improvements.

• Ensure continuous application of ISO standards and Quality System Regulation (QSR) requirements to laboratory and change management processes, both internally and with external partners.

Here Is What You Need

(Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Technical knowledge of laboratory systems, equipment qualifications, laboratory root cause investigations, test method validations, test method transfers, and / or design verification testing

• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues

• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

Bonus Points If You Have

(Preferred Requirements)

• The combination of pharmaceutical and / or medical device