AbbVie Scientist, Quality Control in Worcester, Massachusetts
Independently performs routine and non-routine testing, or supports laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, final Bulk product, stability, and/or validation. Analyzes test data, evaluates results and forms conclusions with minimal outside input.
Is able to recognize laboratory technique or instrumental events that could impact the integrity of the test data. Recognizes and resolves simple to moderately complex technical problems. Writes procedures with minimal guidance. Reviews and verifies data generated by others to determine conformance with product specifications. Works under the general guidance of a supervisor but can effectively manage their own time to ensure timely completion of assigned duties. Trends data to support assay performance.
*Major Responsibilities: * * Performs and/or supports more complex test methods as written to support product/material release with minimal error. * Understands laboratory techniques and principles performed. * Interprets experimental data for conformance with product/material specifications. * Understands, implements and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements. * Assists with writing and performs validation assays per approved protocols. * Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error. * Make recommendations for process improvement. * Writes/revises procedures as necessary and provides support for department. * Develops and maintains trend reports, backlog report, and document error reports which support departmental performance. * Assist in troubleshooting assays.
*Schedule: Must be able to work Saturday and Sunday [as well as three other weekdays] *
Basic: * BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree. * 5 years of related work experience with large molecules * Experience in at least 2 of the following analytical techniques required: HPLC, CE-SDS, SDS-PAGE, ELISA * Experience with Empower CDS preferred * Must be able to work independently, with limited guidance * Maintains their certifications as needed for assigned job tasks
Development, manufacturing, Quality & Regulatory
Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: USA-Massachusetts-Worcester
Req ID: 1706247
Equal Opportunity Employer Minorities/Women/Veterans/Disabled