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QC Stability Associate

Kelly Services

San Mateo, CA
Job Code:
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Job Details

Job Title QC Stability Associate

Jobid US15TPCH_BH1430401

Location: San Mateo, CA, 94403, USA

Description **QC Stability Associate**


San Mateo, CA


Responsible for routine stability responsibilities as described below and directed by the Director of Stability

**Primary Responsibilities:**

+ Training on, understanding of and performing stability responsibilities in compliance with stability program and associated SOPs
+ Training on stability database and performing responsibilities in compliance with stability database SOPs and work processes
+ Design of product stability studies in accordance with SOPs, relevant regulatory requirements and ICH guidance documents
+ Technical review of stability protocols
+ Technical review of stability reports
+ Review of stability data
+ Preparation of trend charts of stability data
+ Completion of time point assessment, expiry establishment, expiry extension and lot specific expiry documentation in compliance with SOPs
+ Tracking of stability study status
+ Assist in preparation of monthly Product Quality Review
+ Assist in preparation of IND or IMPD amendments
+ Assist in preparation of annual reports or DSURs
+ Attendance at routine QC and Quality meetings
**Other responsibilities:**

+ May attend project team meetings
+ May author IND or IMPD sections
+ May act as fill-in admin for stability database when Head of Stability is out of office
+ Other responsibilities as requested by the Head of Stability or Head of CMC Analytics
**Minimum Education and Experience:**

+ Bachelors of science or equivalent
+ Minimum of 5 years in biotechnology/biologics manufacturing
+ Highly preferred direct experience with stability of biotech products
+ Proven ability to self-direct
+ Strong team-oriented working style
**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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