Location: 100% Remote, in the USA
Residency: US Citizen/permanent resident required for US.
Status: Independent Contractor Role.
Client: ELIQUENT Life Sciences ( https://eliquent.com )
This exciting role is for independent contractor instructors with significant experience in the RA/QA aspects of life sciences industry sub-sectors such as medical devices, 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 who have expertise and a passion for patient safety and population health improvement. We offer competitive compensation rates, 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 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 DescriptionConfident 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 QualificationsBachelor's degree in Engineering, Science, or a 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.Leading the instruction of Life Sciences experts in RA/QA matters.Essential Industry RequirementsExperience 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.TravelAbility to travel extensively domestically (25% - 50%). Occasional international travel may be required.
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