Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Requirements

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.)
• 5-8 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.)
• Strong knowledge with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
• Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
• Team player who can operate independently, with strong focus on safety, quality and timelines
• Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment
• Strong attention to detail and commitment to ensuring high standards of quality and compliance
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

Responsibilities

• Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client’s project until project closure
• Supports Clinical QA activities, including initial process development and non-clinical batch production
• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for cGxP integrated contract manufacturing facility
• Ability to troubleshoot, identify process pathways, and develop improvement strategies for site teams on projects/issues
• Understand advanced topics pertaining to cGMP
• Participate in regulatory inspections or customer audits as required
• Understand and articulate company business strategy, maintaining a broad view of the business and recognizing changes and trends
• Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
• Compile lot genealogy and lot disposition packages, driving lot disposition activities to ensure timely product release
• Provide oversight to product status, including preparation of documents for shipping activities
• Oversee the quality tag-out system
• Actively participate in and approve deviation investigations, utilizing Root Cause Analysis tools for effective and timely closure
• Ensure correct implementation of CAPA based on deviations raised and ensure timely closure of CAPA
• Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
• Support changeover activities and QA on call
• Provide training to new members and manufacturing teams
• Provide quality oversight for operations document changes (e.g., MBRs, SOPs, forms, logbooks, etc.)
• Provide quality change request oversight for process and operation changes
• Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections
• Revise, review, and approve SOPs, protocols, reports, and records
• Perform any other tasks as assigned

Preferred Qualifications

No preferred qualifications provided.