Job Description: Quality Assurance Specialist at RxCloud
Position Overview
RxCloud is a premier provider of quality engineering services and regulatory compliance solutions for the life sciences industry. We are seeking a Quality Assurance Specialist to join our dedicated team of professionals. The ideal candidate will play a pivotal role in ensuring that RxCloud and our clients meet and exceed regulatory standards while maintaining the highest levels of quality and efficiency. This position offers an exciting opportunity to work in a dynamic, fast-paced environment focused on pharmaceutical, biotechnology, and medical devices.
Key Responsibilities for Quality Assurance Specialist
Quality Assurance and Compliance:
- Conduct in-depth quality audits (GMP, GDP, GLP, GCP, GVP) for clients across various sectors in the life sciences industry.
- Develop and implement quality management systems (QMS) tailored to client needs.
- Ensure compliance with regulatory standards and guidelines, including FDA, EMA, and ICH.
- Regulatory Support:
- Provide strategic regulatory compliance support for IT systems such as Veeva, Salesforce, TrackWise, Argus, and Documentum.
- Stay updated on the latest changes in regulatory frameworks and advise clients on adapting processes to remain compliant.
- Quality Engineering:
- Perform computer system validation (CSV) and execute both functional and non-functional test automation.
- Oversee CAPA (Corrective and Preventive Action) management and develop standard operating procedures (SOPs).
- Collaborate with cross-functional teams to streamline quality processes and minimize operational inefficiencies.
- Process Improvement:
- Identify and address potential risks in quality processes.
- Drive initiatives to enhance product safety and operational efficiency.
- Optimize workflows to achieve agility without compromising quality.
- Client Engagement:
- Act as a liaison between clients and internal teams to ensure smooth project execution.
- Provide training to client teams on compliance standards and best practices.
- Deliver comprehensive reports and actionable insights post-audit.
Quality Assurance Specialist Qualifications
- Education:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Advanced degrees or certifications in quality management, regulatory affairs, or similar disciplines are a plus.
- Experience:
- 3+ years of experience in quality assurance, regulatory compliance, or quality engineering within the pharmaceutical, biotechnology, or medical device industries.
- Hands-on experience with GxP audits, CAPA management, and computer system validation.
- Skills:
- Strong understanding of quality management systems (QMS) and regulatory frameworks.
- Proficiency with IT compliance tools and systems (e.g., Veeva, TrackWise, Argus).
- Excellent analytical, problem-solving, and decision-making skills.
- Effective communication and interpersonal abilities.
Why Join RxCloud?
- Work with a team that boasts over 1,000 years of combined IT expertise.
- Be part of a mission-driven organization committed to transforming the life sciences industry.
- Gain exposure to cutting-edge technologies and innovative solutions.
- Enjoy a collaborative, inclusive, and growth-oriented work environment.
Key Benefits for Quality Assurance Specialist
- Competitive salary and performance bonuses.
- Comprehensive health and wellness benefits.
- Opportunities for professional development and certifications.
- Flexible work arrangements, including remote options.
Application Process
To apply, please submit your resume and a cover letter highlighting your relevant experience and why you are the ideal candidate for this position. Applications can be sent to info@therxcloud.com.
10 FAQs for the Quality Assurance Specialist Role
- What does RxCloud specialize in?
RxCloud specializes in quality engineering services and regulatory compliance solutions for the pharmaceutical, biotechnology, and medical devices industries. We offer audits, QMS consulting, IT systems assessment, and quality engineering as a service. - What are the key responsibilities of this role?
The role involves conducting audits, ensuring regulatory compliance, developing QMS, performing system validations, managing CAPA, authoring SOPs, and collaborating with clients to enhance quality and efficiency. - What qualifications are required for this role?
A bachelor’s degree in life sciences, engineering, or a related field is required, along with at least 3 years of experience in quality assurance or regulatory compliance. - What industries does RxCloud serve?
RxCloud serves the pharmaceutical, biotechnology, and medical devices sectors, focusing on regulatory compliance and quality engineering. - What is the work environment like at RxCloud?
RxCloud offers a collaborative, innovative, and inclusive work environment that values professional growth and teamwork. - What tools and systems will I work with?
You will work with tools like Veeva, Salesforce, TrackWise, Argus, and Documentum, as well as manage quality processes through CAPA and QMS frameworks. - Does RxCloud provide training or certifications?
Yes, RxCloud encourages professional development by offering training opportunities and support for obtaining industry-relevant certifications. - What are the career growth opportunities?
At RxCloud, you will have the opportunity to grow within the company, take on leadership roles, and expand your expertise in quality engineering and regulatory compliance. - Is remote work an option for this position?
RxCloud supports flexible work arrangements, including remote work options, depending on project requirements and team needs. - How does RxCloud ensure employee satisfaction?
RxCloud focuses on creating a supportive work environment, offering competitive benefits, and fostering a culture of innovation, collaboration, and continuous learning.
