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.
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.
(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
(Preferred Requirements)
The combination of pharmaceutical and / or medical device development experience preferred
Understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems
Experience in laboratory operations, risk management and design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment
Proven ability to succeed in a fast-paced, challenging, and complex environment
Other Job Details
Work Location Assignment: Hybrid - On premise 3 days per week at Parsippany, NJ
PHYSICAL/MENTAL REQUIREMENTS
Comfortable working and making risk-based decisions
Strong interpersonal, communication, and facilitation skills
Ability to succeed in a fast-paced, challenging, and complex environment
Comfortable working in a laboratory setting
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The role may include frequent business travel across Pharmaceutical Sciences, vendors, and suppliers.
Relocation support available
Work Location Assignment: Hybrid
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.
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