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13 days old

Bioanalytical Quality Control Scientist

Kelly Services
Summit, NJ 07901
**Kelly Scientific has been providing outstanding employment opportunities to top talent individuals in the marketplace. We are looking to fill a** **_Bioanalytical Quality Control Scientist_** **role with one of our top clients in** **_Summit, NJ._**


**Title:** Bioanalytical Quality Control Scientist


**Pay: $** 35.26/hr


**Location:** Summit, NJ


**Duration:** 12 months + possible extensions


**Shift:** Day Shift


**Employment Type** : Full time- 40 hrs/wk


Scientist is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products for QC Flow Cytometry Department. This department is responsible for Flow Cytometry based testing of in process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training, and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.


**Duties and Responsibilities:**


Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.


Capable of handling complex issues and solving problems with only general guidance.


Prepare and present continuous improvement projects to management.


Comprehensive understanding of regulatory guidelines and can independently develop, write, and execute methods, protocols, reports, and other related documents.


Review all data in accordance with applicable procedures and cGMP requirements.


Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.


Complete all reviews in accordance with required release timelines.


Complete necessary training to become a qualified trainer.


Perform training effectively.


Document training per procedural and cGMP requirements.


Perform assigned tasks within a CAPA, deviation, or project


Participate in complex projects and continuous improvement efforts.


Draft and review technical documents, such as SOPs and protocols/reports


Communicate effectively with management regarding task completion, roadblocks, and needs.


**Required skills:**


Advanced hands-on experience with various analytical techniques primarily flow cytometry and scientific knowledge in the characterization and transfer of pharmaceutical products.


Advanced ability to understand, follow, interpret, and apply Global accurately and completely


Advanced technical writing skills.


Advanced problem-solving ability/mentality, technically adept and logical.


Ability to represent the interests of the group on cross-functional teams.


Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.


Ability to work with management locally and globally.


Advanced ability to communicate effectively with peers, department management and cross-functional peers.


**Education and Experience:**


Bachelors degree required, preferably in Science (Masters Degree preferred)


0-3 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.


Experience working with polychromatic flow cytometry panels and flow cytometry data analysis preferred.


**Working Conditions:**


+ The incumbent should be able to distinguish colors and possess correctable vision to

+ 20/20, annual eye exam is required.

+ The incumbent must analyze numerical values daily.

+ The incumbent will be working a laboratory setting up to six (6) hours per day.

+ The incumbent will be working around biohazardous materials, including chemical

+ agents up to six (6) hours per day.

+ This job description is intended to describe the general nature and level of work being performed

+ by the person assigned to this position. The primary duties and responsibilities are intended to

+ describe those functions that are essential to the performance of this job.

+ Additional Job Requirements:

+ Position Handles Hazardous Materials


**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 (https://www.mykelly.us/us-mykelly/perks/) ?). 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)


**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: 2021-09-03 Expires: 2021-10-04

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Bioanalytical Quality Control Scientist

Kelly Services
Summit, NJ 07901

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