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16 days old

Manufacturing Specialist GMP Investigations - El Segundo, CA

Kelly Services
El Segundo, CA 90245
**Manufacturing Specialist GMP Investigations** - El Segundo, CA



Manufacturing Specialist: GMP Investigations supports Manufacturing GMP Operation activities in the release of product working on Incident Reports (IRs)/Non-conformances (NCs), Corrective/Preventative Actions (CAPAs) and Change Control Records (CCR).


Essential Functions:




+ Incident Reports (IRs) and Non-conformances (NCs)

+ Open IRs

+ Investigate and determine root cause

+ Work with MFG & Quality to determine corrective actions

+ Collaborate with MFG Leadership, Quality and ENG to determine steps and path for closure

+ Participate and facilitate execution of closure path

+ Write closure memos

+ Track and report IRs/NCs status

+ CAPA

+ Participate in, investigate and determine root causes for repeat occurrences

+ Working with MFG Leadership, Quality and ENG determine and plan the correct actions to be taken

+ Participate, monitor and ensure execution of the corrective action plan

+ Document completion of the plan facilitating closure

+ Track and report CAPA status

+ Change Controls

+ Review open Change Controls

+ Working with MFG Leadership, Quality and ENG determine and steps required to complete the Change Control

+ Drive the completion of the Change Control by completing steps, following up and ensuring others are completing their steps, elevating bogged CRs to MFG Leadership for debugging, ensuring closed steps are documented facilitating closure of the change




Requirements:




+ BA or BS in Science or equivalent

+ Working knowledge of cGMP

+ Cell Culture experience preferred

+ Results driven and business oriented

+ Strong analytical and problem solving skills

+ Strong technical writing skills

+ Ability to work with cross functional teams and build consensus for action

+ Ability to effectively manage change

+ Excellent communication skills (written and verbal)



**For Immediate Consideration, Apply Today! Questions? Call Airika at 562-206-2707 or email at** **airc843@kellyscientific.com**

**To schedule a time to connect, please click the link to add your availability to my calendar.** **https://calendly.com/airc843/30min?month=2020-09**




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2021-01-08 Expires: 2021-02-08

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Manufacturing Specialist GMP Investigations - El Segundo, CA

Kelly Services
El Segundo, CA 90245

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