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Manufacturing Process Technician

Kelly Services

Sacramento, CA
Job Code:
Kelly Services
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Job Details

Job Title Manufacturing Process Technician

Jobid US15TPSA_BH1421157

Location: Sacramento, CA, 95816, USA

Description Manufacturing Process Technician - Sacramento, CA

• Perform and/or monitor production processes for late stage Clinical or FDA approved (Licensed) cGMP manufacturing operations as described in standard operating procedures (SOP’s) and batch records.
• Responsible for completing required cGMP documentation including, but not limited to, deviation reports, change control, product change over, and maintenance records.
• Creation, review and/or revision of cGMP SOP’s, Batch Records and documentation.
• Training and application of cGMP regulations and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.) as it applies to job function.
• Prepare and present data associated with manufacturing processes to internal departments.
• Actively recognize and correct errors in process operations prior to failure.
• Implement new systems, process improvements equipment, and procedures.
• Recommend projects and execute changes to process operations to reduce risk, increase efficiency and increase proficiencies of compliance requirements and departmental policies.
• Participates in validation/qualification activities including process validation and equipment /system IQ/OQ/PQ.
• Participates in Process development/Manufacturing process transfer activities
• Participate in shipping/receiving, warehousing and production support activities (dispensing and kitting).
• Participate in onsite inventory management program, inventory adjustments, and year-end physical inventory activities.
• Ensure adherence of all relevant cGMP requirements for warehousing, shipping/receiving and production support (dispensing and kitting).
• Other responsibilities or duties as assigned
• Our manufacturing center runs operations 7 days per week; must be willing to work Wednesday through Saturday or Sunday through Wednesday
• Bachelor’s degree in related field or equivalent work experience.
• Minimum of 2 years experience performing late stage Clinical or FDA approved (Licensed) Cell Therapy Manufacturing Processes.
o Must have direct experience of standard manufacturing procedures and operations including:
-Operations in a cleanroom environment
-Cryopreservation of cellular components
-Cell separation
-Operation and use of Single Use Technology
-Aseptic/sterile technique
-Process measurement and/or analysis
o Experience with and understanding of current Good Manufacturing Practices (cGMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.)
• Experience with bringing biotechnology equipment and processes from design through GMP operational readiness
• Must be self-motivating, organized and proactive with multi-departmental tasks and deliverables (interaction with PD, Eng., QA, QC, etc.).
• Technical aptitude and experience of applying scientific reasoning to solve complex problems.
• Experience successfully managing multiple tasks in parallel
• Experience working with or within a CMO.
• Computer skills including work with spreadsheet programs (Excel) and word processing (Word).

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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