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QC Associate Scientist
Ref No.: 20-00574
Location: Summit, New Jersey
If you are interested to apply on below req - Please send an updated resume to Anant.K@sunrisesys.com or Banu.P@sunrisesys.com. You can also call us at 262-222-8865 or 224-242-9590.

Actual Job Title = __QC Associate Scientist - Multiple Opening (Bulk Hiring)

Purpose and Scope of Position

The QC Associate Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. 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

•Hands on experience with various bioanalytical techniques including ELISA, qPCR and FACS/Flow Cytometry.
•Ability to accurately and completely understand, follow, interpret and apply Global

Regulatory and cGMP requirements.
•Technical writing skills.
•Problem solving ability/mentality, technically adept and logical.
•Ability to represent the interests of the group on cross-functional teams.
•Ability to set priorities of the group and manage timelines.
•Ability to work with management locally and globally.
•Ability to communicate effectively with peers, department management and cross- functional peers.

Duties and Responsibilities

•Perform testing of in-process, final product, and stability samples.
•Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
•Anticipate and troubleshoot problems.
•Recommend corrective actions and participate in development of best practices.
•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.
•Work and communicate effectively within the team to ensure timelines are met.

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 review in accordance with required release timelines.
· Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
•Document training per procedural and cGMP requirements.
· Draft and revise 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.

Education and Experience

•Bachelor's degree required, preferable in Science.
•3-5 years of relevant work experience, preferable in a regulated environment.