Senior Associate, Quality Control Analyst
We are currently seeking a strong Senior Quality Control Analyst to join our AbbVie Bioresearch Center in Worcester, MA. This senior leader will perform, lead, analyze and document laboratory tests within a GMP environment in support of one or more of the following areas; raw materials, in-process product, finished product, stability, and/or validation.
This resource will use scientific education and their experiences to generate results in accordance with GMP/ procedural requirements and scientific principles. Additionally, this resource will interpret data output to determine conformance with product specifications, perform trend analyses for assays, review and verify data generated by others to determine conformance with product specifications.
Lastly, they will need to understand internal business process to make appropriate prioritization of their assigned work duties and duties of others in the lab, have experience and command of multiple laboratory techniques to perform them with minimal error and train other laboratory personnel on any technique they currently have in their training matrix.
- Leads and influences analysts in QC with their tasks and activities.
- Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
- Proposes and implements changes to maintain procedural requirements.
- Performs, leads, analyzes and/or documents analytical test methods as written to support product/material release with minimal error.
- Proposes and implements changes to improve laboratory techniques and methodology.
- Independently troubleshoot and resolve analytical techniques and instrument issues.
- Interprets experimental data for conformance with product/material specifications.
- Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
- Initiates appropriate exception documents in accordance with procedural requirements.
- Implements and ensures improvement ideas are completed to facilitate team objectives.
- Proposes and implements scientific protocols to determine exception event cause.
Position will be hired based on level of experience.
- BS degree in Science or equivalent and 8+ years of relevant experience
- Experienced with key analytical techniques: CE-SDS, ELISA, SDS-PAGE and HPLC
- Method validation experience preferred
- Previous GMP experience required
- Experience in training other analyst to perform laboratory procedures and assays preferred
- Participate in internal assessments and audits as required
- Calibrate, validate, or maintain laboratory equipment as required
- Maintains their certifications as needed for assigned job tasks.
- Demonstrates strong analytical skills and logical thought process.