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 Incoming Quality Assurance Specialist will ensure that critical and key raw materials and supplies that are received meet raw material specifications set forth by SCA Pharmaceuticals and have appropriate certificates of analysis and certificates of conformance prior to releasing to inventory. These responsibilities will be performed at the production site as well as the warehouse site. In addition, the individual in this position will be responsible for maintaining and improving existing processes, as well as assisting in the design and development of new processes, in the areas of Incoming Quality Assurance release requirements, trending of received material specifications, assisting with recalls of raw materials, assisting with raw material specification creation, and coordinating raw material specification changes. 

Essential functions:

• Inspect and release raw materials and supplies related to production and commercial operation in a controlled cGMP environment
• Review inspection documentation (COA, COC, or other Material Certifications) for inbound materials as well as check-weighed and returned to stock materials against receiving documentation.
• Ensure discrepancies are investigated thoroughly, documented, and approved or rejected in a timely manner 
• Facilitate rejection process for critical and key materials not conforming to specifications, as required both physically and in the ERP system.
• Complete area audits and provide feedback when correction is warranted.
• Trend receipt of incoming materials for historical specification review
• Verify Waste quantities prior to destruction
• Assist with COA and COC requests from suppliers
• Coordinate activities related to the incoming raw material verification program, including, but not limited to obtaining samples, submitting samples, liaising with vendors, and trending and analyzing data
• Assist with recall of raw material, including supporting procurement communication and quarantining material electronically
• Improve internal quality processes (such as incoming inspection) and offer Quality support to other departments (Quality Management System & Operations Quality), as needed
• Scan, file, and archive QA related documents
• Support RSPEC creation, as needed
• Additional responsibilities as assigned

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline preferred
• 1+ years of quality experience in pharmaceutical, medical device or other related industries preferred
• Minimum of 1 year of material approval/release experience

Desired Knowledge, Skills, and Abilities:

• Proficient in the Microsoft Office Suite (Excel, Word, Outlook)
• Have effective communication (both written and verbal).
• Ability to work independently with minimal supervision and collaboratively with cross functional teams
• Ability to accommodate shift schedule. Shifts may include routine weekend and evening work as required by the manufacturing process
• Ability to accommodate unplanned overtime (including nights and weekends) on little to no prior notice

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.