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22 days old

Quality Batch Release Specialists

Kelly Services
Allentown, PA 18103
Kelly Science & Clinical is currently seeking **Quality Batch Release Specialists** for a long-term engagement with one of our Global Pharma clients out of West Point, PA


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. 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:**

Perform batch record review and disposition for COVID-19 VACCINE produced at external manufacturing sites


**Key Responsibilities:**

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

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.

Perform batch disposition in accordance with Supply Chain procedures.

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

Generate OMCL/CBER protocols for lot release

Enter data into eLIMS

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

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


**Required Experience/Knowledge:**

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

Minimum of 4 years working in a pharmaceutical regulated environment

Experience with pharmaceutical aseptic processing operations or quality assurance Detailed knowledge of cGMPs related to pharmaceutical production

Strong interpersonal and written/oral communication skills

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

Advanced degrees are a plus and may reduce the experience required


**Preferred Experience/Knowledge**

Experience in vaccines production

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

Proficient in applying process excellence tools and methodologies

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. 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: 2021-03-24 Expires: 2021-04-24

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Quality Batch Release Specialists

Kelly Services
Allentown, PA 18103

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