Jobs / United States / Pfizer INC
Senior Quality Assurance Compliance Specialist
Pfizer INC · 🇺🇸 United States - Michigan - Rochester
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 40 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Pfizer INC
The US Department of Labor certified 40 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Pfizer INC →
About the role
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 (CAPA) responses to internal and external audit observations for adequacy, effectiveness, and timely completion. • Ensure Quality Assurance policies, procedures, and quality system records remain current and compliant with applicable regulatory requirements, corporate quality requirements, and site procedures. • Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments, ensuring timely development, implementation, and closure of resulting action plans. • Manage, investigate, and document customer quality complaints for commercial drug products within the global complaints management system, ensuring thorough root cause analysis, timely investigations, and appropriate quality decisions. • Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners to ensure complaint investigations and quality records are completed in accordance with established procedures and regulatory expectations. • Support the Supplier Quality Management Program through supplier qualification, monitoring, performance trending, issue escalation, supplier corrective action management, and quality risk assessments, as applicable. • Assist with technical investigations involving product, process, component, and equipment-related quality issues, providing quality oversight and support for testing activities and protocol execution. • Collect, analyze, interpret, and trend quality and operational data using appropriate statistical and risk-based methodologies to identify opportunities for continuous improvement and risk mitigation. • Review quality system documentation and performance metrics, conduct trend analysis, and identify emerging issues requiring corrective or preventive action. • Promote and ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, data integrity principles, and company procedures. • Support quality investigations, deviation management, change management, effectiveness verification activities, and continuous improvement initiatives across site quality systems. • Prepare reports, presentations, and quality metrics to communicate findings, risks, recommendations, and quality system performance to management and stakeholders.. Here Is What You Need (Minimum Requirements) • High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS 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 • Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks • Excellent technical writing, communication, and presentation skills • 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 syst