Quality Assurance Manager

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 Quality Assurance Manager leads a cross-functional Quality Assurance team. The QA Manager is responsible for ensuring GMP compliance and adherence to SOPs for all operations, including but not limited to label/log generation, material picking and sanitization, sterile compounding, cleaning/sanitization of the aseptic areas, inspection, labeling and packaging, warehouse and shipping processes, microbiological and chemical analytical testing.

Essential functions:

• Drive delivery of day-to-day Quality Assurance activities, ensuring adherence to expected cycle times
• Provide advice and knowledge when interpreting GMP guidelines and regulations
• Lead the back room during regulatory agency inspections and customer audits and support inspection readiness, and post inspection activities
• Provide oversight of the site document control function, which includes review, editing, issuing documents, performance of MasterControl Document Control Role, Document Room management, off-site documentation storage and retrieval management, logbook creation (as needed)
• Responsible for site internal audit program. Serves as lead and back up auditor for site audits. Promotes closure and follow up of audits
• Review and approve new SOPs, as well as changes to existing SOPs, to assure enhanced quality and productivity, while maintaining compliance with SCA and US FDA requirements
• Report quality metrics to members of Leadership Team at scheduled intervals (weekly, monthly & quarterly) and in response to requests for information
• Proactively look for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance
• Review and approve various Quality System documents that include, but are not limited to, CAPAs, change controls (MOCs), LSPECs, PSPECs and other updates made to site specific and company wide documents
• Review and approve batch related non-conformance reports (e.g. DEVs, EVENTs, EXCs, CMS, etc.)
• Schedule employees in regard to workload and backlog to ensure efficiency.
• Train and mentor direct reports as needed
• Drive to root cause during process investigations
• Maintain strong communication and relationships with internal customers and peers

Required Qualifications & Experience:

• Bachelor’s degree in in life sciences, engineering, or related discipline.
• 5+ years of quality experience in pharmaceutical, medical device or other related industries.
• 3+ years of supervisory experience

Desired Knowledge, Skills, and Abilities:

• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Strong written and verbal communication skills.
• Proven ability to work cross-functionally to achieve business outcomes
• Familiarity with regulatory requirements for 503(b) sterile compound outsourcing facilities
• Leadership, critical thinking, decision making Demonstrates skill in maintaining internal customer relationships.
• Effectively lead and train employees.
• Strong attention to detail
• Goal oriented, with excellent time management and organizational skills

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.