Scientist I, Quality Control (1st Shift, M-F)

Employer
AbbVie
Location
Worcester, MA, US
Posted
Aug 10, 2019
Ref
1905498
Required Education
Bachelors Degree
Position Type
Full time
We are currently seeking a Scientist in Quality Control - 1st Shift to join our team at the AbbVie Bioresearch Center in Worcester, MA. The QC Scientist will perform cGMP laboratory testing in support of one or more of the following areas: in-process product, final bulk product, stability, and/or validation. The QC Scientist role will also be responsible for data mining and performance of routine trend monitoring of quality control analytical test results and test method performance. Where trends are observed, the QC Scientist will be responsible for performing Laboratory Investigations, Potential Nonconformity Reports and/or Nonconformity reports to identify root cause and implement corrective actions.

The ideal candidate will have a strong background in quality control laboratory testing of biologics products (experience in HPLC and CE-SDS and/or ELISA methodology) and shall be experienced with lab investigation methodologies (hypothesis testing, root cause analysis, and CAPA planning/execution). The ideal candidate will also have a strong data analytics background with capabilities to mine and aggregate data from structured databases as well as perform basic statistical functions to analyze the data for trends.

Key Responsibilities Include:

  • Performs complex test methods as written to support product/material release and/or validations
  • Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements
  • Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements
  • Strong technical writing and communication skills
  • Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives
  • Revises procedures as necessary and provides continuous improvement support for the department
  • Support laboratory investigations in a timely manner
  • Make recommendations for process improvements and help with implementation
  • Assist in assay troubleshooting


  • BA/ BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree
  • 5-8 years of related work experience
  • HPLC and Capillary Electrophoresis and/or ELISA experience
  • Spectrophotometric concentration determination
  • Laboratory investigation experience

Preferred:

  • Empower software experience
  • Working knowledge of advanced laboratory instrumentation