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CMC Documentation Associate (Tech Transfer)

Kelly Services


Location:
Philadelphia, PA
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US51FPAG_BH1441775
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Job Details

Job Title CMC Documentation Associate (Tech Transfer)

Jobid US51FPAG_BH1441775

Location: Philadelphia, PA, 19133, USA

Description **CMC Documentation Associate (Tech Transfer)**

**Position Overview:**

This position will be responsible for keeping the technical operations records up to date with current production information, and generating reports that aid for transparency across the cross-function teams.

**Responsibilities:**


+ Enter production / QC data from global productions at contract manufacturing sites
+ Create and distribute trending reports for production and QC parameters
+ Create and distribute trending reports for production and dose delivery performance at each contract manufacturing site
+ Track receipt, review, reconcile and archive drug product batch files
+ Compilation of batch file review comments and organize distribution to contract manufacturing sites
+ Follow investigations, issues, and troubleshooting tickets from opening to closure to ensure each continues to move towards closure to ensure reliability
+ Document the details of the investigations, issues, and troubleshooting process from opening to closure
+ Prepare and distribute daily summary reports on global manufacturing status of investigations, issues, and troubleshooting tickets
**Basic Qualifications:**


+ B.S. in Chemistry or related field preferred
+ 1-2 years of experience in a GMP regulated environment
+ Qualified candidates must be legally authorized to be employed in the United States. The company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
**Additional Skills/Preferences:**


+ Impeccable organizational skills
+ Excellent computer skills, proficiency in Microsoft Excel, PowerPoint, and Word
+ Knowledge of cGMP drug substance/drug product manufacturing and quality control
+ Knowledge of Microsoft Access
**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 kellyservices.com 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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