Supplier Quality Specialist

Scapharma; Windsor (CT); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Supplier Quality Specialist to enhance its quality systems. This role involves ensuring suppliers meet stringent quality standards, conducting audits, and managing supplier performance metrics. With a commitment to providing high-quality medications, this dynamic company fosters a collaborative environment where your contributions will significantly impact patient care. If you are passionate about quality assurance in the pharmaceutical sector and thrive in a fast-paced setting, this is the perfect opportunity for you.

Qualifications

• Mindestens 2 Jahre Erfahrung im Qualitätsbereich der pharmazeutischen Industrie.
• Kenntnisse über regulatorische Anforderungen für 503B Outsourcing-Einrichtungen.

Responsibilities

• Unterstützung aller Elemente des Lieferantenqualitätsystems.
• Durchführung externer Lieferantenaudits zur Sicherstellung der Qualitätsstandards.

Skills

Qualitätsmanagement

Regulatorische Anforderungen

Kommunikationsfähigkeiten

Detailorientierung

Organisationsfähigkeiten

Education

Bachelor-Abschluss in Lebenswissenschaften

Bachelor-Abschluss in Ingenieurwesen

Tools

Microsoft Office Suite

Job description

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Description

SCA Pharmaceuticals is a dynamic, rapidly growing company composed of passionate individuals dedicated to our mission of providing high-quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility offering customized medications for hospitals and healthcare facilities across the United States. We achieve this through unyielding quality, safety, integrity, our commitment to accountability and ownership, teamwork, and creating better solutions by simplifying the complex.

Summary

The Supplier Quality Specialist plays a key role in the Quality Systems organization by ensuring that suppliers meet SCA’s Quality standards. The role involves evaluating potential new sources of supply, selecting appropriate suppliers based on assessments, audits, quality performance, risk profiles, and internal requirements. The individual will also lead the enhancement of the supplier qualification program as regulations evolve.

Essential Functions

• Support all elements of the supplier quality system, including:
• New supplier qualification (questionnaires & risk assessments)
• Routine supplier re-evaluation
• Approved supplier list (ASL) management
• Non-conforming material containment
• Perform external supplier audits to ensure quality standards are met
• Escalate critical or repeated observations from audits or compliance gaps
• Issue supplier complaints and follow-up for corrective actions
• Measure and communicate supplier performance through trend analysis and metrics
• Monitor supplier notifications and changes for compliance with Quality Agreements
• Manage development and implementation of Supplier Quality Agreements
• Assess impact of FDA Warning Letters on suppliers
• Coordinate external testing of raw materials with laboratories
• Establish and maintain specifications for incoming raw materials
• Maintain repository for supplier documentation
• Ensure processes meet CFR and 503B standards
• Author quality documents, including SOPs
• Perform other quality system duties as assigned

Requirements

Required Qualifications & Experience

• Bachelor’s degree in life sciences, engineering, or related field
• At least 2 years of quality experience in pharmaceutical, medical device, or related industries
• Familiarity with regulatory requirements for a 503B outsourcing facility or related sterile pharmaceutical manufacturing and cGMP knowledge

Desired Skills and Abilities

• Proficiency in Microsoft Office Suite
• Strong communication skills
• Detail-oriented with good organizational skills
• Experience with regulatory inspections (FDA, notified bodies)
• Ability to work cross-functionally and independently
• Willingness to spend time in warehouse environments for raw materials
• Willingness to travel (~15%) for external audits
• Ability to multitask and identify roadblocks early

SCA Pharma is an equal opportunity employer, recruiting without regard to race, religion, gender, or other protected categories.