CenterWatch

1+ months

QC Stability Associate (part-time)

Kelly Services
San Mateo, CA 94403
**QC Stability Associate**


Kelly Scientific is searching for a part-time QC Stability Associate to be responsible for routine stability in an analytical chemistry, virtual lab. This position will be with an emerging biotechnology company in San Mateo.



**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, Master's degree preferred

+ 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, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


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




**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: 2019-08-19 Expires: 2019-10-24

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QC Stability Associate (part-time)

Kelly Services
San Mateo, CA 94403

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