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QC Data Review Consultant

Job Attributes

Job Id:

19854

Job Category:

Clinical & Life Sciences

Job Location:

Warren, NJ  07059

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is seeking a dedicated QC Data Review SME (flow cytometry) in Warren, NJ to support a data transformation initiative for a global biopharmaceutical corporation. This is initially a 6-month project, with potential for extension.

 

The QC Data Reviewer is responsible for performing as a subject matter expert in the completion of the Quality Control bioanalytical testing or data review in direct support of clinical and commercial manufacturing activities. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.  Additionally, this position will be responsible for training and may participate in assay transfer.

 

Qualifications include:

  • Advanced hands on experience with various analytical techniques including FACS, ELISA, qPCR, and scientific knowledge in the characterization and transfer of pharmaceutical products

 

Regulatory and cGMP requirements.

  • Advanced ability to interact with regulatory auditors as Subject Matter Expert (SME).

  • Advanced technical writing skills.

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

 

Responsibilities include:

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

  • Handling complex issues independently

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

Compensation for the QC Data Review SME:

  • Commensurate to experience
  • Benefits; Medical, Dental, & Vision

Please send all qualified resumes to Karen Pallone at kkpallone@pipercompanies.com

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Job Id:

19854

Job Category:

Clinical & Life Sciences

Job Location:

Warren, NJ  07059

Security Clearance:

No Clearance

Business Unit:

Piper Companies