Quality Assurance (QA) Manager
About The Position
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 (QA) Manager leads a cross-functional Quality Assurance team. The Quality Assurance (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.
Requirements
- 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
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
