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11 days old

Batch Release Data Entry (Pharma)

Kelly Services
Durham, NC 27722
**Batch Release - Data Entry**


**Durham, NC**


Kelly Science and Clinical is hiring a **Data Entry Batch Release** to work directly with one of our major pharmaceutical clients. This role is a full-time, salaried opportunity offering our enhanced benefit package. As a Kelly employee within this group, you will be eligible for our benefit options including Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly FSP employees receive annual performance reviews.


Must be local to: Durham, NC


Key Responsibilities:


+ Maintain oversight for status of individual batches, including all manufacturing process step start dates, sampling, testing, deviations, and release timelines

+ Provide daily status updates of all batches on behalf of CMO/EQ team

+ Update EM batch tracker and intake form (if applicable) at CMO daily with updated dates of process steps and investigations

+ Oversee status of all open investigations, batch release timing, and communicate Quality project lifecycle for the COVID-19 Vaccine Quality function on behalf of the assigned CMO

+ Collaborate with EQ team and CMO to ensure daily updates are accurate

+ Conduct daily query of deviations and investigations at site

+ Gather daily updates from EM site regarding deviations and investigations and work with Global Investigations team to ensure all Data Tracking Sheets are updated

+ Communication when needed regarding alerts of any nonconforming results, out of trend, or out of specification results

+ Understand risk and delays to batch release and communicate appropriately

+ Manage/track OMCL/CBER samples from final shipment to government facility

+ Build relationship and influence external partners to continuously enhance Quality culture and business excellence

+ Apply cGMP regulations and other FDA internal requirements to all aspects of the position


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-06 Expires: 2021-11-06

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Batch Release Data Entry (Pharma)

Kelly Services
Durham, NC 27722

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