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28 days old

Senior Scientist of Quality Control

Kelly Services
Durham, NC 27722
Kelly Scientific is currently seeking an **Senior Scientist of Quality Control** for a **DIRECT HIRE** opportunity in **Durham, NC.**



The QC Sr. Scientist will possess leadership responsibility to manage and support QC Metered Dosage Inhalaler (MDI) finished product testing operation to include a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will provide guidance to junior staff and work as a member of team to effectively plan QC analytical testing using established (official and/or in-house) test procedures. The QC Sr. Scientist may execute 50% - 70% of their work at the bench level.



**Responsibilities:**




+ Perform assigned sampling, physical, chemical tests and assay on active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascase impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.

+ Write method transfer/verification protocols and reports for QC management.

+ Train new and existing QC Scientists on instrumentation and methodologies.

+ Establish and manage QC metric, data trending, and drive actions for department improvements.

+ Provide in-lab leadership to junior staff.

+ Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work as well direct junior level staff.

+ Independently plan and execute testing to meet established time lines. Perform complicated testing.

+ Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.

+ Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.

+ Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.

+ Perform troubleshooting and investigations under the direction of a supervisor.

+ Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.

+ Review of Analytical documents as required

+ Other duties as required





**Requirements:**




+ Degree (BS, MS, PhD) in Chemistry, Pharmaceutical Sciences, or related field

+ BS with 10+ years of experience, MS with 8+ years of experience, or PhD with 6+ years of experience with a majority of experience being in Analytical testing

+ 5+ years QC experience in Generic Pharmaceutical industries is preferable

+ Experience in a cGMP environment is required

+ Experience with Inhaled Dosage forms is required

+ Knowledge and use of Good Documentation practices is required

+ Knowledge of USP/ICH/FDA is required

+ Ability to learn quickly and make sound, scientifically driven decisions that adhere to regulatory practices is required



Apply Today for Immediate Consideration!






**Why Kelly** **** **?**



Kelly Science 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: 2020-06-10 Expires: 2020-07-11

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Senior Scientist of Quality Control

Kelly Services
Durham, NC 27722

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