Quality Specialist jobs in United States
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Surf Search · 2 hours ago

Quality Specialist

Surf Search is seeking a Quality Specialist to join their pharmaceutical client's growing quality team. This role is responsible for leading supplier oversight, audit readiness, and corrective action systems within a regulated pharmaceutical environment, ensuring compliance and supporting inspection preparedness.

Staffing & Recruiting
Hiring Manager
Lindsey Bozzio
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Responsibilities

Design, implement, and maintain supplier quality and compliance programs for regulated vendors
Monitor and evaluate the performance of material, product, and service providers
Lead qualification and onboarding of new suppliers
Draft, review, and manage quality agreements with external partners
Collaborate with internal stakeholders across operations, sourcing, and commercial teams to review supplier performance metrics
Establish and maintain supplier risk assessment and monitoring processes
Manage supplier change notifications and ensure internal systems are updated accordingly
Coordinate and oversee supplier corrective action activities to ensure timely and effective resolution
Maintain accurate records related to vendor history, approvals, risk assessments, and performance trends
Develop and administer internal and external audit schedules and procedures
Own and manage the corrective and preventive action (CAPA) system, including tracking and reporting effectiveness
Promote continuous improvement initiatives throughout quality operations
Support regulatory agency inspections and third-party audits, including preparation and response activities

Qualification

FDA GMP regulationsPharmaceutical manufacturingAudit planningExecutionAnalytical problem-solvingStakeholder managementWritten communicationVerbal communicationLeadership skillsOrganizational skillsTime-management skills

Required

In-depth understanding of FDA GMP regulations and quality systems
Familiarity with pharmaceutical manufacturing and processing workflows
Strong written and verbal communication abilities
Effective leadership, negotiation, and stakeholder management skills
Advanced analytical and problem-solving capabilities
Experience planning, executing, and documenting audits
Ability to interpret complex regulatory and operational data
Sound judgment in ambiguous or fast-changing environments
Strong organizational and time-management skills
Ability to balance multiple priorities and resolve conflicts productively
Proactive approach to identifying and addressing compliance risks

Company

Surf Search

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As a boutique firm, we are able to take the time to understand our clients and their business.

Funding

Current Stage
Early Stage

Leadership Team

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Debbie Winkelbauer
CEO | (800) 713-3532 | dwink@surfsearch.org
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Jan Hudson
COO | 800.713.3532 | www.surfsearch.org
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