Quality Control Specialist 503B

🏢 Summary: Senior Associate role supporting regulated laboratory informatics systems from requirements gathering through testing, validation, deployment, and post-implementation support. The position partners with laboratory, operations, quality, and technical stakeholders to deliver compliant, fit-for-purpose solutions in a hybrid work arrangement. 🗂️ Requirements: MS/MA in a science-related discipline with 1+ years of industry experience, or BS/BA with 3+ years of industry experience, Understanding of solution development lifecycle activities in a regulated or quality-driven environment, Written and verbal communication skills, Organization skills to manage multiple priorities, timelines, and stakeholders, Microsoft Office 365 proficiency, Authorization for permanent employment in the United States, Availability for occasional evening and weekend work 📃 Skills: SDLC, cGLP, Validation, UAT, Microsoft365, LIMS, LabWare, SAS, SQL, ChatGPT, Copilot 🏢 Description: Use Your Power for Purpose In a world driven by rapid knowledge creation and supported by advanced technology platforms, Pfizer's digital and 'data first' strategy aims to accelerate the development of impactful technology solutions for research, development, and medical functions. By fostering collaboration and information sharing through business technology, we strive to help employees discover the best healthcare solutions for our patients. As part of a team of innovators, you will play a crucial role in maintaining our systems and ensuring the security of our information. We seek dedicated colleagues like you to enhance the quality of patient care through fresh ideas and cutting-edge information technology solutions. Your expertise in informatics will be instrumental in advancing R&D by developing, supporting, and validating computer systems. You will generate high-quality assay data within a regulated cGLP (current Good Laboratory Practice) laboratory environment to bolster Pfizer’s research initiatives and streamline processes. Leveraging your technical and documentation prowess, you will ensure regulatory compliance for the Research Department’s software solutions. As an associate, your dedication to the job will drive the completion of project tasks and objectives. Your domain knowledge and commitment will foster a collaborative atmosphere among your colleagues. It is your diligence and focus that will empower Pfizer to reach new milestones and provide aid to patients worldwide. What You Will Achieve As a Senior Associate, you will play a key role in translating business needs from laboratory and operations teams into practical info system solutions. You will partner with functional assay leads, operations leads, laboratory SMEs, and informatics partners to define requirements, support solution design, coordinate user testing, and manage project activities across the solution development lifecycle (SDLC). Your work will help ensure that info systems supporting regulated laboratory processes are fit for purpose, properly tested, and supported by appropriate documentation for validated environments. How You Will Achieve It Partner with functional assay leads, operations leads, laboratory SMEs, and informatics partners to understand business needs and translate them into info system solutions. Elicit, document, and maintain business and end-user requirements for new solutions and enhancements to existing solutions. Support solution design discussions by ensuring proposed system functionality aligns with laboratory workflows, operational needs, compliance expectations, and end-user requirements. Project manage assigned system initiatives through the solution development lifecycle, including requirements gathering, design review, testing, validation readiness, deployment support, and post-implementation follow-up. Develop, review, and execute user acceptance testing activities to confirm system functionality meets approved business and end-user requirements. Guide end users through testing activities, support test execution, document results, capture defects, and coordinate issue resolution with the technical teams. Generate, review, and maintain documentation supporting validated systems, including requirements, test scripts, SOPs, change controls, and related project deliverables. Facilitate regular project meetings with business stakeholders and technical partners to review priorities, status, risks, decisions, and action items. Collaborate with quality, validation, laboratory, and technical teams to ensure system deliverables are aligned with regulated system expectations. Maintain strict compliance with departmental, site, and corporate training, quality, and safety requirements. Here Is What You Need (Minimum Requirements) MS/MA in a science-related discipline such as computer science / mathematics or biological science with 1+ years of hands-on industry experience. Or BS/BA with 3+ years of hands-on industry experience. Understanding of solution development lifecycle activities in a regulated or quality-driven environment. Strong written and verbal communication skills. Strong organizational skills with ability to manage multiple priorities, timelines, and stakeholders. Proficient in Microsoft Office 365 applications. Bonus Points If You Have (Preferred Requirements) Experience supporting validated systems in a pharmaceutical, biotech, laboratory, or regulated environment. Familiarity with laboratory informatics systems such as LabWare LIMS and statistical analysis applications such as SAS. Experience creating documentation such as requirements, test scripts, traceability matrices, SOPs, or user guides. Experience working with cross-functional teams across business, quality, and technical organizations. Working knowledge of SQL and basic understanding of computer programming language. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use. Non-standard Work Schedule, Travel Or Environment Requirements Occasional evening and weekend work to meet critical deliverables. Work Location Assignment: Hybrid The annual base salary for this position ranges from $82,700.00 to $137,900.00. 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. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Information & Business Tech