26 days old

Quality Assurance Manager

Kelly Services
Boulder, CO 80305
Quality Assurance Manager - Direct Hire

107K per year

The Quality Assurance GCP/GLP Manager is responsible for arranging, conducting and reporting on GCP audits of clinical research organizations, vendors, and systems as well as oversight of the Clinical Operations and Clinical Trials. Participates in cross-functional teams providing guidance and risk-based options. Reviews study documents and checks for consistency and appropriate standards and practices. Assists in the creation and maintenance of audit tools. When appropriate, prepares and/or revises GCP/GLP SOPs and Work Instructions. Works with cross-functional teams to provide GCP and GLP advice. Maintains good working relationships and communication with GCP/GLP customers and staff. Essential duties include: Performs Quality Control QC of clinical and non-clinical data. Ensures Clinical Operations and Trials are complaint with FRA and ROW regulatory expectations. Arranges, conducts and reports on GCP audits of clinical research organizations, investigators, vendors, and systems. Arranges, conducts and reports on GLP audits of clinical research organizations, investigators, vendors, and systems. Develops and maintain quality procedures aligned with GCP and GLP concepts. Work within a cross-functional team, ensuring compliance to regulatory guidance and internal document management standards. Work directly with CRO s and other external contractors and collaborators, managing the chain of communication related to GCP compliance.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-07-24 Expires: 2019-08-24

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Quality Assurance Manager

Kelly Services
Boulder, CO 80305

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