Affiliate Consultant - Life Sciences

Vision Achievement
US - District of Columbia - Washington
September 22, 2024

Location: 100% Remote, in the USAResidency: US Citizen/permanent resident required for US.Status: Independent Contractor Role.Client: ELIQUENT Life Sciences (***)#lifesciences, #consultant, #RAQA

This exciting role is for independent contractors with significant experience in the RA/QA aspects of life sciences industry sub-sectors such a medical device, in vitro diagnostics, lab developed tests, pharmaceuticals and cosmetics.

You will likely be an expert in designing, manufacturing and monitoring RA/QA under 21 CFR 2XX and 8XX sections and have wide life sciences experience.

We seek consultants, auditors and instructors and those who have expertise and a passion for patient safety and population health improvement. We have good rates of compensation, defined by project, and a top-rated team to work alongside you.

The roles are home based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology. We therefore seek highly organized individuals who are self-starters, good communicators and are open to flexible work arrangements, seeking variety in the work they do.

You would be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product. The role is primarily that of an individual contributor, although teamwork is expected.

Person Description

Confident personality and competent in getting ideas across to others effectively
Demonstrates ability to work in a team environment, especially when operating remotely
Passion for patient or consumer safety through effective regulatory and quality activities
Respects the contribution of all colleagues and facilitates consensus on tough issues
Demonstrates flexibility in day-to-day working in the team and in approach to unique client issues
Established as an independent contractor or contract-for-hire

Essential Base Qualifications

Bachelors degree in Engineering, Science, or and Life Sciences related field
Evidence of progressively taking more responsibility and leading activities in their field (such as writing regulatory submissions)
Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, cosmetics.

Essential Industry Requirements

Experience with design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
Experience with quality systems planning and implementation, design control and process validation
Experience with submissions, remediation, clinical evaluation, post market surveillance, risk management
Experience with ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus

Travel

Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.

Required Skills:
• Remediation
• GMP
• Life Sciences
• Codes
• Consulting
• Compensation
• Validation
• Travel
• Risk Management
• Infrastructure
• Manufacturing
• Contractors
• Writing
• Regulations
• Teamwork
• Planning
• Design
• Engineering
• Science
• Management

Salary Package:
$ 125.00 - 225.00 (US Dollar)

Read the full job description and apply online on the recuiter's web-site

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