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29 days old

QA QC Specialist III

Kelly Services
Lexington, MA 02421
Kelly Services is currently seeking a QA/QC Specialist III to work with a leading biopharmaceutical company in Lexington MA.


Duration: 1 year


Pay rate: $45 per hour


+ Small molecule API and drug product lab testing experience is a must, HPLC, GC, FTIR, KF, dissolution, etc.

+ Has experience review data, experienced in working with CMOs and 3rd party testing labs. Experienced in lab troubleshooting, investigations.

+ GMP compliance, familiar with regulations and ICH guidelines.


This position is responsible for oversight of QC activities conducted at CMO labs and contract test labs (CTLs) for drug product and APIs. Provide technical support and quality oversight to third part testing laboratories.


Primary duties of the position are focused around non-laboratory support of the QC functions.


Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.


Lead or support analytical and manufacturing investigations of unexpected results to identify root cause (e.g. Out Of Specification (OOS)/Atypical (AT) laboratory investigations) and defines and implements corrective or preventive actions. Provide impact assessment and help drive to closure.


Develops testing plans and support method transfers as needed. Authoring analytical protocols, stability protocols. study plans, reports.


If interested please reply with an updated copy of your resume for consideration!


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-09-27

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QA QC Specialist III

Kelly Services
Lexington, MA 02421

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