SCA Pharma · 23 hours ago
Quality Assurance (QA) Manager
Little Rock, AR
Full-time
Onsite
Senior Level
5+ years expSCA Pharmaceuticals is a dynamic rapidly growing company committed to providing high quality medications. The Quality Assurance (QA) Manager leads a cross-functional team to ensure GMP compliance and adherence to SOPs for all operations including quality systems oversight and continuous improvement initiatives.
Health CarePharmaceutical
Responsibilities
Provides oversight of the key quality systems (ex. Deviation, Change Control and CAPA) by tracking status and progress, and reporting Key Quality Indicators (KQI) to site leadership
Responsible for the continuous improvement and implementation of the Incoming Quality Assurance (IQA) program, Manufacturing Quality Assurance (MQA) program, and Batch Record Release (BRR) program, as applicable
Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule
Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations
Responsible for ensuring the SCA SOPs, Batch Records and Forms are compliant with cGMPs, cGDPs, and consistent with other SCA policies and procedures
Reviews and approves investigations (including, but not limited to, deviations, Out-of-Specification, Environmental Monitoring Excursions) and provides advice and knowledge during investigation to ensure appropriate root cause and corrective actions are determined
Reviews and approves raw material and finished product specifications
Reviews and approves internal audits, supplier complaints and customer complaints
Reviews and approves new and revised SOPs, Change Controls and CAPAs
Schedules employees regarding workload and backlog to ensure efficiency
Proactively looks for opportunities to identify change, increase efficiency, influence decisions, and deliver results while ensuring compliance
Responsible for hiring, training and development of direct reports
Additional responsibilities as assigned
Qualification
Required
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
Preferred
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
Company
SCA Pharma
SCA Pharma is an FDA 503B outsourcing facility delivering the highest quality sterile admixtures and pre-filled syringes to hospitals.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Enhanced Healthcare Partners
2021-01-21Private Equity
2021-01-21Acquired
2017-10-05Series Unknown
Leadership Team
Gina Durand
Human Resources Business Partner
Hugh O'Neill
Chief Commercial Officer
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase