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Quality Assurance Associate

Responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables.  Responsible for supporting the business in Quality Assurance, through audit activities in support of ongoing quality improvement.  Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices. 


Quality Assurance Implementation
  • Executes assigned actions related to the corporate Quality Plan.
  • Liaises with internal stakeholders to facilitate the development/revision and review of QMS, SOPs, Work Instructions, Associated Documents, standards, and training materials as required
  • Evaluate quality processes against corporate standards and regulatory requirements.
  • Supports audits (internal, site, vendor) and reviews associated Corrective Action and Preventive Actions (CAPA’s).
  • Provides guidance, as required, to internal stakeholders related to the interpretation of GCP and regulatory requirements.


Regulatory, Ethical Conduct and Audit Monitoring
  • Remains current on and communicates changes to relevant regulatory requirements and industry standards. 
  • Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations.
  • Supports Sponsor and regulatory inspections or audit activities.


Quality Assurance Training
  • Identifies, creates, adapts, and delivers quality assurance orientation as well as department, project team and clinical site quality assurance training programs. 
  • Initiates training plan creation and manages the training database. 
  • Liaises with Human Resources to communicate training assignments. 


Qualifications
  • The successful candidate will possess either an undergraduate degree with 1-3 years of related experience and on the go training, or a College Diploma with 4-6 years of related experience and training.
  • Clinical Research, Quality Assurance or Information Technology experience preferred. Analytical, critical thinking, problem solving and attention to detail skills required. Strong computer skills required. Basic knowledge of ICH GCP and global regulations governing Clinical Research. 


$51,500 - $86,000 a year

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.

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Average salary estimate

$68750 / YEARLY (est.)
min
max
$51500K
$86000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Assurance Associate, Alimentiv

Are you passionate about ensuring quality in clinical research? Join Alimentiv as a Quality Assurance Associate, where you'll play a key role in supporting the development, implementation, and ongoing maintenance of our Quality Management Systems (QMS). In this exciting position, you'll not only be responsible for auditing activities that drive quality improvement but also act as a vital link between various business units and partners. You will execute essential actions tied to our corporate Quality Plan while liaising with internal stakeholders to refine our QMS, Standard Operating Procedures (SOPs), and training materials. Your keen eye for detail will help you evaluate quality processes against regulations, ensuring compliance at every step. Plus, you’ll support audits and help craft corrective action plans. With your expertise, you will provide guidance on GCP and regulatory requirements, keeping the team informed on crucial changes in standards and industry practices. Not to mention, you'll take charge of the Quality Assurance Training programs, creating comprehensive orientation sessions and managing our training database. If you hold an undergraduate degree with some experience, or a College diploma with more experience, this role offers you an excellent opportunity to thrive in the fast-paced world of clinical research. Join us at Alimentiv and contribute to a culture of quality while advancing your career!

Frequently Asked Questions (FAQs) for Quality Assurance Associate Role at Alimentiv
What are the main responsibilities of a Quality Assurance Associate at Alimentiv?

As a Quality Assurance Associate at Alimentiv, your role will primarily focus on supporting and maintaining the Quality Management Systems (QMS). This involves liaising with various internal departments to ensure compliance with corporate standards, aiding in audit activities, providing guidance on regulatory requirements, and creating quality assurance training programs. Essentially, you'll help ensure that processes meet regulatory standards and drive initiatives for ongoing quality improvement.

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What qualifications do I need to apply for the Quality Assurance Associate position at Alimentiv?

To qualify for the Quality Assurance Associate role at Alimentiv, you should have either an undergraduate degree with 1-3 years of related experience and ongoing training or a College Diploma with 4-6 years of relevant experience. A background in Clinical Research, Quality Assurance, or Information Technology is preferred, along with strong analytical, critical thinking, and problem-solving skills.

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How does the Quality Assurance Associate at Alimentiv contribute to audits and regulatory inspections?

In your role as a Quality Assurance Associate at Alimentiv, you will support both internal and external audits and regulatory inspections. Your responsibilities will include reviewing Corrective Action and Preventive Actions (CAPAs), ensuring that the processes adhere to GCP and regulatory requirements, and communicating any necessary changes to stakeholders. This crucial involvement helps maintain high quality and compliance standards across the organization.

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What skills are essential for success as a Quality Assurance Associate at Alimentiv?

To excel as a Quality Assurance Associate at Alimentiv, strong analytical skills and attention to detail are essential. You should also possess good problem-solving abilities, proficiency with computers, and a foundational understanding of ICH GCP and global regulations governing Clinical Research. These skills will be critical in evaluating quality processes and ensuring compliance with corporate and regulatory standards.

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What does the training aspect of the Quality Assurance Associate role at Alimentiv entail?

The training responsibilities of the Quality Assurance Associate at Alimentiv involve creating, adapting, and conducting quality assurance orientation programs for new hires and ongoing training for department and project teams. You will collaborate with Human Resources to track and communicate training assignments, ensuring that all staff remain knowledgeable about quality standards and practices.

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Common Interview Questions for Quality Assurance Associate
Can you describe a time when you identified a quality issue in a project?

When answering this question, think of a specific instance where you noticed a quality deviation. Explain the situation clearly, detailing the actions you took to investigate and address the issue, as well as the outcome. Highlight the importance of your attention to detail and analytical skills in resolving the problem.

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How do you stay updated with changes in Quality Assurance regulations?

Discuss the methods you use to stay informed on quality assurance regulations, such as subscribing to relevant industry publications, participating in training sessions, or being part of professional organizations. Share tangible examples that demonstrate your proactive approach toward continuous learning.

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What process do you follow to conduct an internal audit?

In your response, outline the audit process you typically follow, which may include planning, conducting interviews, reviewing documentation, and reporting findings. Emphasize the importance of thoroughness and clear communication throughout the audit process.

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What is your experience with Corrective Action and Preventive Action (CAPA) processes?

Detail your experience with CAPA processes, providing specific examples of situations where you identified a non-compliance issue, implemented corrective actions, and monitored the results. Highlight how you collaborated with teams to prevent similar issues in the future.

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How would you handle a disagreement with a colleague regarding quality standards?

Show your interpersonal skills by explaining how you would approach a disagreement. Focus on the importance of open communication, actively listening to the colleague’s perspective, and working together to ensure that quality standards are met.

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How do you prioritize your tasks in a fast-paced environment?

Share your strategies for prioritization, such as using task lists, deadlines, and assessing the impact of each task on the overall project. Highlight how effective time management contributes to maintaining quality assurance standards.

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What tools or software are you familiar with for managing quality assurance?

Discuss any relevant software or tools you have used in your previous roles that helped streamline quality assurance activities, such as QMS software or audit tracking tools. Provide examples of how these tools improved efficiency in your work.

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Can you explain the significance of GCP in clinical research?

Clearly articulate what Good Clinical Practice (GCP) is, emphasizing its role in ensuring the integrity and safety of clinical research. You might mention that GCP guidelines help protect the rights of participants and ensure reliable data.

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How do you approach developing training programs for quality assurance?

Talk about your process for creating effective training programs, which could involve assessing training needs, developing content, and evaluating training effectiveness. Share how you align training with organizational objectives and participant roles.

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What do you believe is the biggest challenge facing Quality Assurance professionals today?

Give your insights into current challenges in Quality Assurance, such as increasing regulations, the need for technology adaptation, or maintaining quality amid rapid change. Describe how you would address these challenges in your role.

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Full-time, remote
DATE POSTED
March 16, 2025

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