SCA Pharma
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Supplier Quality Specialist
role at
SCA Pharma .
SCA Pharmaceuticals is a dynamic, rapidly growing company that believes in our mission of providing high‑quality medications critical for saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility that customizes medications for hospitals and healthcare facilities across the United States.
Summary The Supplier Quality Specialist plays a key role in the Quality Systems organization by ensuring that suppliers meet SCA’s Quality standards. The specialist evaluates potential new sources of supply and selects appropriate suppliers based on supplier assessments, audits, quality performance and systems, risk profile, and internal SCA requirements, and leads the enhancement of an appropriate 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, and approved supplier list (ASL) management.
Contain non‑conforming material and 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 the quality of SCA manufactured products.
Manage the development and implementation of Supplier Quality Agreements.
Assess impact to SCA when suppliers receive Warning Letters from FDA.
Coordinate external testing of raw materials with contract laboratories.
Ensure appropriate specifications are established and maintained for incoming raw materials and that only approved materials can be received.
Maintain a 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 (SOPs).
Perform other Quality System duties as assigned, such as internal audits and customer complaint investigations.
Required Qualifications & Experience
Bachelor’s degree in life sciences, engineering, or a related discipline.
2+ years of quality experience in pharmaceutical, medical device, or related industries.
Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge 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 organizational skills with the ability to provide strategic and improvement recommendations.
Some exposure to regulatory agency inspections (e.g., FDA, notified bodies).
Proven ability to work cross‑functionally to achieve business outcomes.
Ability to spend time in a warehouse environment to quarantine raw materials.
Ability to travel (≈15%) required to perform external audits.
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.
Location:
Rocky Hill, CT |
Salary:
$95,000.00 – $110,000.00 |
Employment Type:
Full‑time |
Seniority Level:
Entry level
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Supplier Quality Specialist
role at
SCA Pharma .
SCA Pharmaceuticals is a dynamic, rapidly growing company that believes in our mission of providing high‑quality medications critical for saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility that customizes medications for hospitals and healthcare facilities across the United States.
Summary The Supplier Quality Specialist plays a key role in the Quality Systems organization by ensuring that suppliers meet SCA’s Quality standards. The specialist evaluates potential new sources of supply and selects appropriate suppliers based on supplier assessments, audits, quality performance and systems, risk profile, and internal SCA requirements, and leads the enhancement of an appropriate 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, and approved supplier list (ASL) management.
Contain non‑conforming material and 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 the quality of SCA manufactured products.
Manage the development and implementation of Supplier Quality Agreements.
Assess impact to SCA when suppliers receive Warning Letters from FDA.
Coordinate external testing of raw materials with contract laboratories.
Ensure appropriate specifications are established and maintained for incoming raw materials and that only approved materials can be received.
Maintain a 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 (SOPs).
Perform other Quality System duties as assigned, such as internal audits and customer complaint investigations.
Required Qualifications & Experience
Bachelor’s degree in life sciences, engineering, or a related discipline.
2+ years of quality experience in pharmaceutical, medical device, or related industries.
Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge 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 organizational skills with the ability to provide strategic and improvement recommendations.
Some exposure to regulatory agency inspections (e.g., FDA, notified bodies).
Proven ability to work cross‑functionally to achieve business outcomes.
Ability to spend time in a warehouse environment to quarantine raw materials.
Ability to travel (≈15%) required to perform external audits.
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.
Location:
Rocky Hill, CT |
Salary:
$95,000.00 – $110,000.00 |
Employment Type:
Full‑time |
Seniority Level:
Entry level
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