NEW JOB OPENING QA SPECIALIST IN OCEANSIDE, CA, USA!

Job Description
Education & Experience
Candidates must meet one of the following requirements:
• Master's Degree in Biological Sciences or related field; OR
• Bachelor's Degree with 2+ years of relevant experience; OR
• Associate's Degree (AA) with 4+ years of relevant experience; OR
• High School Diploma with 5+ years of relevant experience

Technical Knowledge
• Quality Control experience in:
o Analytical Testing
o Virological Testing
o Microbiological Testing
• Strong understanding of:
o GMP regulations
o U.S. regulatory requirements
o EU regulatory requirements

Key Responsibilities
Quality Assurance Operations
• Perform QA-related production and production support activities.
• Review and approve Batch Records.
• Conduct Line Clearance activities.
• Provide on-the-floor QA support during manufacturing operations.
• Perform routine walk-throughs and process observations.
Quality Control Oversight
• Provide QA review and approval of Quality Control activities, including:
o Method Transfers
o Certificates of Analysis (CoA)
o Stability Programs
Product Release & Packaging
• Approve product shipments.
• Provide QA oversight during product packaging activities.
• Communicate lot disposition status and pending issues to management.
Quality Systems Management
• Assess and ensure timely closure of:
o Deviations
o CAPAs (Corrective and Preventive Actions)
o Change Controls
o Laboratory Investigations
o Batch Hold Events
o Material Hold Events
Compliance & Regulatory Support
• Ensure products are manufactured in accordance with:
o GMP requirements
o Regulatory guidelines
o Company quality standards
• Support regulatory inspections and audits.
• Identify and escalate compliance risks to management.
• Escalate issues that could impact timely product release.
Documentation & Training
• Generate, revise, and update SOPs, procedures, and forms.
• Perform document control activities, including:
o Document archival
o Training record updates
• Support site training documentation maintenance.

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**

Benefits:
For information and details on employment benefits offered with this position, please visit here . Should you have any questions/concerns, please contact our HR Department via our secure website .

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here .

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department .

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).