Quality Assurance and Regulatory Affairs (QA/RA) Professional

Company Overview:

At Intelygic, we are a dynamic and innovative technology company, committed to delivering cutting-edge solutions through high-quality and scalable applications. Our projects often involve conceptualizing and executing complex, challenging solutions tailored to meet the needs of our clients.

About the Role:

We are seeking experienced Quality Assurance and Regulatory Affairs (QA/RA) professionals to join our team on a part-time or consulting basis for a Quality Management System (QMS) development project. We can accommodate W2 or 1099. This role may become permanent in future and as 1099 can continue on long-term basis.

The successful candidate will play a key role in explaining end-to-end process flows for various QMS modules, detailing different components/contents topics within a given module and mapping interactions with regulations, standards, management reviews, and risk modules. This role also involves verifying process flows, conducting peer reviews, and ensuring compliance with industry standards and regulatory frameworks.

Responsibilities: ? Provide expert guidance on end-to-end processes of QMS modules and sub-modules. ? Review and verify process and workflow documentation for accuracy and completeness. ? Ensure workflows adhere to best practices and meet ISO and regulatory standards in the U.S. and Europe. ? Peer-review project outputs to confirm alignment with laid-out objectives.

Qualifications:

Experience:

Minimum 7 years of experience working in the Quality department of a manufacturing organization within a regulated industry.

Required Experience:
? Must have QA related certification(s).
? In-depth understanding of end-to-end processes for at least one QMS module and its sub-modules.
? Expertise in QMS documentation and workflow management.
? Should be able to identify use cases for QMS module(s), sub-modules, and related activities.
? Must be able to establish a clear link of any activity within a QMS with regulatory standards.
? Hands-on experience with management reviews and QA audits (internal/external).

Preferred Experience:
? Writing use cases, testing scripts, and validation documents.
? Designing and generating workflows using tools like Visio or other workflow software.
? Familiarity with software tools such as e-QMS, MES, PLM, ERP, CRM, or HRMIS.

Soft Skills:
? Strong attention to detail and logical thinking.
? Problem-solving skills to address and resolve process gaps effectively.
? Excellent communication and collaboration skills.
? Proactive, well-organized, and capable of working independently.

What We Offer:
? Competitive compensation, based on experience and expertise.
? Flexible working hours are tailored to suit your schedule.
? Opportunities for professional development and learning.
? A collaborative and supportive work environment.
? A chance to contribute to a meaningful and impactful project.

If you are passionate about quality management systems and have the expertise to contribute to an innovative project, we?d love to hear from you! Apply today to join our team and help shape the future of QMS solution.

Equal Employment Opportunity (EEOC) Statement: Intelygic is an equal opportunity employer and values diversity in the workplace. We are committed to creating an inclusive environment for all employees and contractors, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status. We encourage applications from all qualified individuals.

Job Types: Part-time, Contract

Pay: Up to $200.00 per hour

Expected hours: 5 ? 20 per week

Benefits:
? Flexible schedule

Location:
? United States (Required)

Work Location: Remote

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