24 days old

Project Lead

Kelly Services
Durham, NC 27722
Kelly is currently seeking a Project Lead for a long-term engagement with one of our Global Pharmaceutical clients.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

**Summary of Assignment**

Oversee all open investigations, batch release timing, and communicate quality project Lifecyle for the CV-19 Vaccine Quality function. The incumbent is the Account Manager s right hand.

Key Responsibilities:

+ Provide quality support for the Vaccine External Manufacturing site.

+ Ensure effective and compliant execution of quality systems at the EM sites.

+ Participate in deviation review, development of corrective action plans, and monitor implementation

+ Provide cGMP compliance support to EM by investigating and resolving quality issues e. Coordinate and provide concurrences on deviations

+ Monitor quality performance of EM g. Work closely with the Janssen Account Manager, Person in Plants, Batch release personnel and partner with the CMO to deliver business and quality goals with agility.

+ Author, revise, review, and approve Quality System documents

+ Maintain oversite for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly

+ Develop tracking mechanisms for internal and external investigations

+ Gather daily updates from External Manufacturers regarding investigations and batch releases across entire quality project lifestyle

+ Daily query to analyze and understand any project needs/investigations m. Track timeliness of quality needs and raise awareness of those coming due

+ Facilitate daily triage meetings with in-depth understanding of current quality issues/needs o. Ensure appropriate quality processes is followed and all documentation complete

+ Communicate and manage any notifications to appropriate parties

Required Experience/Knowledge:

+ Bachelor s degree with a concentration in engineering, science, or an equivalent technical discipline

+ Knowledge and experience with aseptic process operations or quality assurance.

+ Experience in quality investigations and quality systems 03/10/2021

+ Strong interpersonal and written/oral communication skills to include information sharing with senior leaders e. Fundamental knowledge of drug manufacturing processes

+ Experience in a regulated environment

+ Experience with project management

+ Good organizational capabilities

+ Professional proficiency in English

+ Microsoft programs

+ Preferred knowledge: a. Vaccines production b. Working with external manufacturers

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-03-22 Expires: 2021-04-22

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Project Lead

Kelly Services
Durham, NC 27722

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