22 days old

Batch Release Data Entry (Pharma)

Kelly Services
Baltimore, MD 21217
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:

Baltimore, MD

**Data Entry (Batch)**

1. Quality systems and planning roles. Provides daily updates on behalf of CMO/EQ team: batch status and release updates. Update GDI/intake form implemented at CMO daily with updated dates of process steps and investigations. Collaborate with EQ team/onsite resources to ensure updates are accurate. Understand risks/delays to batch status

**Batch Release/Batch Release Coordinator**

1. Key Responsibilities

1. Maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly.

2. Review batch documentation provided by external manufacturing site for compliance with cGMPs, standards, and product specifications. Ensure all required testing and documentation is provided and meets release requirements.

3. Perform batch disposition in accordance with Supply Chain procedures

4. Manage/track OMCL/CBER samples from EM to final shipment to government facility

5. Generate OMCL/CBER protocols for lot release

6. Enter data into eLIMS

7. Alert Supervision of any nonconforming results, out of trend, or out of specification results

8. Support supply chain logistics for on time shipment from CMO to Warehouse

2. Required Experience/Knowledge

1. Bachelors Degree with a concentration in engineering, science, or an equivalent technical discipline

2. Minimum of 4 years working in a pharmaceutical regulated environment

3. Experience with pharmaceutical aseptic processing operations or quality assurance

4. Detailed knowledge of cGMPs related to pharmaceutical production

5. Strong interpersonal and written/oral communication skills

6. Ability to quickly process complex information and make critical decisions with limited information required

7. Advanced degrees are a plus and may reduce the experience required

3. Preferred Experience/Knowledge

1. Experience in vaccines production

2. Experience in the OMCL/CBER process for vaccine government approval/release

3. Proficient in applying process excellence tools and methodologies

4. Experience 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 (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. (


Posted: 2021-11-05 Expires: 2021-12-06

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Batch Release Data Entry (Pharma)

Kelly Services
Baltimore, MD 21217

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