QA Reviewer (Cell and Gene Therapy Environment) - 1730460
Title: Quality Assurance (QA) Investigator Reviewer – Cell and Gene Therapy Environment
Location: Maryland, USA (Onsite Work) 🌎
Positions Available: 4
Are you passionate about upholding the highest standards in Quality Assurance within the Cell and Gene Therapy or biologics field? We are currently seeking four (2) dedicated and detail-oriented Quality Assurance (QA) Investigators Reviewers to join our client’s team in Maryland, USA. In this role, you will play a critical part in maintaining compliance and quality in a dynamic, cutting-edge environment, helping to drive innovation and ensure the safety and efficacy of groundbreaking therapies. 🧬✨
Requirements:
Education and Experience:
- Bachelor's degree in a relevant scientific discipline.
- Proven experience in a QA role within the Cell and Gene Therapy or biopharmaceutical industry. 🎓💼
Availability:
- Immediate availability for interviews, with the ability to start right away if selected. 📅🚀
Responsibilities:
Thorough Review of Investigations:
- Conduct comprehensive reviews of deviation investigations, including minor, major, and critical incidents. Ensure investigations meet quality standards and regulatory requirements, safeguarding product integrity and patient safety. 🧪🔍
Technical Writing Skills:
- Document investigation findings accurately and clearly using strong technical writing skills. Ensure that reports reflect scientifically sound methodologies and adherence to regulatory standards. 📝🔬
Cross-Functional Collaboration:
- Collaborate effectively with cross-functional teams, including Manufacturing, Quality Control, and Regulatory Affairs, ensuring a cohesive approach to problem-solving across all aspects of the investigation. 🤝🚀
Keeping Investigation Boards Updated:
- Regularly manage and update the board of investigations, maintaining accurate records to reflect the current status of each investigation. Ensure transparency and effective tracking throughout the investigation process. 📊📄
Participation in Hall Meetings:
- Attend and actively contribute to hall meetings, providing updates on ongoing investigations. Use these meetings to align team efforts and address any issues in a timely manner. 💬👥
Focus on 'Right First Time':
- Emphasize achieving 'right first time' by ensuring investigations are thorough and accurate from the outset, reducing the need for revisions and maintaining high standards of quality and compliance. 🎯✔️
Accomplishments in Reducing Backlog:
- Highlight significant accomplishments in reducing backlogs of investigations. Demonstrate a strong ability to efficiently address and resolve overdue investigations, contributing to improved operational efficiency. ⏳📈
Root Cause Analysis:
- Lead and support investigations into deviations, non-conformances, and product quality issues. Conduct root cause analyses and ensure that CAPAs are developed, implemented, and tracked for effectiveness. 🌱🔧
Regulatory Compliance:
- Ensure that investigations comply with FDA, EMA, and other regulatory standards, maintaining adherence to cGMP and industry regulations. 📑🌐
Data Analysis and Reporting:
- Analyze data trends to identify recurring issues and communicate findings to management. Provide recommendations for process improvements to enhance quality systems. 📊📈
Audit Participation and Response:
- Support internal and external audits by preparing documentation and responding to audit findings related to investigations and quality issues. 🕵️♂️📊
Continuous Improvement:
- Identify opportunities for improvement in investigation processes and quality systems, actively contributing to the implementation of best practices. 🚀🔄
Training and Development:
- Provide training and guidance to team members on conducting investigations and maintaining quality compliance, fostering a culture of continuous improvement. 📚👨🏫
Knowledge:
- Strong familiarity with FDA regulations, cGMP requirements, and regulatory expectations in the context of Cell and Gene Therapy. 📚💡
Communication Skills:
- Excellent written and verbal communication skills to effectively collaborate with internal teams and external stakeholders. 🗣️✉️
Attention to Detail:
- Exceptional attention to detail with a commitment to maintaining the highest quality standards. 👁️📏
If you are a dedicated QA professional with experience in Cell and Gene Therapy or biologics and are ready to contribute to a leading-edge operation, we encourage you to apply. Be part of a mission to shape the future of healthcare. 🌟👩⚕️
To apply, please submit your resume to careers@proqualitynet.com. Only shortlisted candidates will be contacted for interviews.
ProQuality Network is committed to providing a safe and inclusive workplace for all employees. 🌈🤝