System One Services Quality Specialist - Packaging & Inspection in Baltimore, Maryland
Quality Specialist - Packaging & InspectionBaltimore, MD
Category:Scientific & Clinical
Title: Quality Specialist CAPA
Location: Baltimore, MD
Type: Full Time, Salaried with benefits
• Perform QA activities such as product and labeling visual over-inspections, in-process audits on GMP floor, and on the floor batch record reviews
• Partner with Operations to meet schedule requirements and resolve challenges
• Support / assist timely closure of CAPAs, gap analyses, and product complaints
• Maintain company quality and safety standards
• Author and revise standard operating procedures (SOPs)
• Lead Packaging Quality on the Floor improvement initiatives
• Train new Pkg Quality on the Floor personnel on related procedures
• Initiate deviations and assist in area investigations
• Track and trend Pkg QOTF data for monthly metrics reporting
• Train Packaging & Inspection personnel to help resolve issues
• Bachelor’s degree in relevant field with 3-5 years of GMP experience required; QA/QC role preferred
• Must possess strong attention to detail.
• Ability to navigate computer programs such as Veeva (Document Management System) and SAP (ERP System).
• Proficient knowledge of CGMP.
• Strong communication (written and verbal) and organizational skills.
• Ability to independently manage multiple priorities in a dynamic environment.
• High level of personal/departmental accountability and responsibility.
• Creatively use business concepts and company policies/procedures to solve problems.
• Excellent complex problem-solving and teamwork skills.
• Proficient at resolving issues in creative and innovative ways.
• Exercises good judgment in selecting methods/techniques to achieve positive results.
• Understand and respond appropriately to a diverse population.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.