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Bioanalytical QC Scientist (Flow Cytometry)

  • Location: Summit, Union, New Jersey
  • Job Type:Contract

Posted 21 days ago

  • Expiry Date: 30 September 2021

Job Description:

  • The QC Associate 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 inprocess 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.

Required competencies: knowledge, skills, and abilities:

  • 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 accurately and completely understand, follow, interpret and apply Global

  • Regulatory and cGMP requirements.

  • 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.

  • Advanced 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.

Duties and responsibilities:

  • Perform testing of the in-process, final product, and stability samples.

  • 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.

  • Complete all work in a timely manner.

  • Perform peer review of testing data.

  • 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.

  • Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

  • Train new analysts to general job duties.

  • Complete necessary training to become a qualified trainer.

  • Perform training effectively.

  • Document training per procedural and cGMP requirements.

  • Support document revision, project, CAPA, and investigation/deviation tasks.

  • Perform assigned tasks within a CAPA, deviation, or project

  • Participate in complex projects and continuous improvement efforts.

  • Take a leadership role, as required, for projects.

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

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

  • Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.

  • Performs other tasks as assigned.

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 on a daily basis.

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.