Supplier Quality Specialist

Description

SCA Pharmaceuticals is a dynamic, rapidly growing company consisting of passionate individuals who believe in our mission of providing high-quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety, and 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 Supplier Quality Specialist will evaluate potential new sources of supply and select appropriate suppliers based on supplier assessments, audits, quality performance and systems, risk profile, and internal SCA requirements. The individual in this position will lead the enhancement of an appropriate supplier qualification program as regulations in this area evolve.

Essential functions:

• Support all elements of the supplier quality system including:
• New supplier qualification (supplier 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 serious compliance gaps to appropriate Quality leadership.
• Issue Supplier Complaints and follow-up to ensure corrective actions are addressed for all material issues.
• Measure and communicate supplier performance through routine trend analysis and establish ongoing supplier quality metrics.
• Monitor notifications and changes implemented by suppliers to ensure compliance with respective Quality Agreements, and quality of SCA manufactured products.
• Manage the development and implementation of Supplier Quality Agreements
• Perform assessments to determine impact to SCA when Suppliers are issued Warning Letters by FDA
• Coordinate the external testing of raw materials with contract laboratories.
• Ensure appropriate specifications are established and maintained for incoming raw materials and ensure only approved materials can be received.
• Maintain repository for supplier documentation (both electronically and physically)
• Ensure supplier quality processes meet CFR and 503B standards.
• Author Quality documents for the site including standard operating procedures (SOP’s).
• Performs other Quality System duties as assigned (e.g., Internal Audits, Customer Complaint Investigations, etc.).
  
  
  

Requirements

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline
• 2 years of quality experience in pharmaceutical, medical device, or other related industries.
• Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
  
  
  

Desired Knowledge, Skills, and Abilities:

• Proficient in Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint)
• Strong written and verbal communication skills.
• Detail oriented and strong organization skills with the ability to provide strategic and improvement recommendations/solutions.
• Some exposure to regulatory agency inspections (e.g., FDA, notified bodies, etc.).
• Proven ability to work cross-functionally to achieve business outcomes.
• Ability spend time in a warehouse environment to quarantine raw materials.
• Ability to travel (:15%) required to perform external audits.
• Ability to multitask efficiently and identify roadblocks prior to project milestones.
• Strong communication skills driving organizational engagement.
• Ability to be flexible in a fast-paced environment.
• Ability to work independently with minimal supervision and collaboratively with cross functional teams.
  
  
  

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.