QC Analyst 1

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

1d•$23 - $35

About The Position

As Quality Control Analyst 1, your activities will support assay development through commercial application of new and innovative service offerings within the biosafety testing space. You are responsible for the scientific integrity of technical work performed in the laboratory, and are required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of company testing services, technical principles and applications as they apply to your position.

Requirements

Bachelor’s Degree in scientific discipline (e.g., Biology, Chemistry, Biotechnology, etc.)
High school diploma or GED with 4+ years’ experience with laboratory practices, techniques, equipment, materials and mathematical calculations.

Nice To Haves

Knowledge and experience in chemistry, microbiology, and/or cell culture desired.
Ability to independently manage various assignments
Basic skills in applicable computer programs
Excellent oral and written communication skills
Works well in both independent and collaborative environments

Responsibilities

Performs environmental monitoring activities in Microbiology and Cell Culture cleanroom environments.
Performs basic GMP material control testing on raw materials, finished products and components.
Performs water utilities sample collection and testing.
Operates and maintains lab equipment as required by SOPs and testing procedures.
Performs data entry of QC test data across multiple databases.
Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
Performs daily tasks using proper documentation as required.
Performs peer review of assay batch/lab records to ensure Right First Time (RFT)
Performs tasks in accordance with SOPs and regulations (cGMP and GLP).
Maintains complete and comprehensive records for data integrity.
Maintains a standard upkeep of the facility through daily cleaning.
Performs monthly facility inspection of GMP lab area.
Works on assignments that are complex in nature where judgment is required in solving problems and making routine recommendations.
Interacts with all levels within the laboratory and interacts with other areas of the company on a limited basis.
Communicates deviations/ events, progress and interim results to Study Management.
Assists with routine filing and archiving of lab documents and records.