[Hiring] Quality Assurance Associate @Alimentiv 2

Alimentiv 2; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Associate to join their remote team. This role involves supporting the development and maintenance of Quality Management Systems and ensuring compliance with regulatory standards. The ideal candidate will have a strong analytical mindset and problem-solving skills, along with a background in Clinical Research or Quality Assurance. You'll be responsible for conducting audits, providing training, and liaising with various stakeholders to enhance quality processes. If you're passionate about quality improvement and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• Undergraduate degree with 1-3 years of experience or College Diploma with 4-6 years.
• Preferred experience in Clinical Research, Quality Assurance, or IT.

Responsibilities

• Support the development and monitoring of Quality Management Systems.
• Liaise with stakeholders to facilitate QMS and training material development.

Skills

Analytical skills

Critical thinking

Problem solving

Attention to detail

Strong computer skills

Education

Undergraduate degree

College Diploma

Tools

Quality Management Systems (QMS)

Standard Operating Procedures (SOPs)

Job description

Mar 18, 2025 - Alimentiv 2 is hiring a remote Quality Assurance Associate. Location: Canada.

Responsibilities:

1. Responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables.
2. Responsible for supporting the business in Quality Assurance, through audit activities in support of ongoing quality improvement.
3. 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:

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

Regulatory, Ethical Conduct and Audit Monitoring:

1. Remains current on and communicates changes to relevant regulatory requirements and industry standards.
2. Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations.
3. Supports Sponsor and regulatory inspections or audit activities.

Quality Assurance Training:

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

Qualifications:

1. 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.
2. 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.