Description
Manufacturing Support Specialist
Monday-Friday 8am-5pm
Contract role
$30-$40/hour
Must have electronic batch record experience required.
About the Job
This role involves supporting manufacturing operations to ensure compliant, efficient, and reliable production processes. As the facility operates 24/7, flexibility with working hours may be required.
Job Description
What You'll Do:
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Lead operational readiness efforts and support commissioning and qualification activities during the project phase
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Troubleshoot issues within assigned process areas
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Recommend and execute documentation updates
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Coordinate non-batch activities, including documentation for tech transfer, equipment changeovers, preventive maintenance plans, and column packing
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Create and manage records for change control, investigations, CAPAs (Corrective and Preventive Actions), and continuous improvement initiatives
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Drive and implement improvement projects within drug substance manufacturing
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Collaborate with cross-functional teams to support equipment startup and transition to GMP operations
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Use documentation to configure electronic batch records for specific products and processes
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Work with stakeholders to define process steps, parameters, and sample requirements for electronic batch records
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Support inspections and audits by preparing and providing necessary documentation
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Perform other duties as assigned
Basic Requirements:
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High School Diploma or GED with 6 years of relevant experience OR
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Associate degree with 4 years of direct experience OR
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Bachelor's degree with 2 years of direct experience OR
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Equivalent military training/experience
Preferred Qualifications:
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Associate or Bachelor's degree in life sciences or engineering
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Experience with Manufacturing Execution Systems (MES), preferably Syncade
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Experience with Electronic Document Management Systems (EDMS), ideally Veeva
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Completion of BioWorks or BTEC Capstone cGMP coursework is a plus
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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