Quality Control Technician II

The businesses of Merck KGaA, Darmstadt, Germany•Jaffrey, NH

2d•$19 - $30•Onsite

About The Position

We are seeking an Intermediate-level Microbiology Lab Quality Control Technician to support critical testing operations within our biopharmaceutical quality program. This role is responsible for conducting bacterial retention testing of filtration membranes and devices, with a strong focus on maximizing safety, quality, and productivity. The technician will contribute to day-to-day laboratory operations by performing basic troubleshooting of test set-ups and retention testing processes and will work within a Laboratory Information Management System (LIMS) to support accurate and compliant data management. This is a D shift position Fri - Sun 6AM- 6PM. Duties include: Test products safely and in accordance with Standard Operating Procedures, Quality and Safety Specifications and GMP standards. Safely set up and operate quality lab test equipment and monitor required inputs and outputs. Support quality lab operations and projects under the supervision of senior technicians. Accurately complete documentation per GMP standards. Initiate and participate in Out of Specification (OOS) investigations. Assist with execution of protocols, qualifications, and validations. Develop skills to independently perform Bacterial Retention Testing. Ensure a clean and orderly workspace and have proactive identification of safety, quality, and productivity concerns. Actively report hazardous conditions or hazardous behaviors observed in the work center and the site. Perform basic troubleshooting and test set-ups; review, verify, and accurately enter test and process data into the Laboratory Information Management System (LIMS); participate in sustainability efforts; and carry out assigned tasks under close supervision.

Requirements

1+ years of laboratory or cGMP manufacturing experience.
High school diploma or GED.

Nice To Haves

Associate’s degree in any discipline.
2+ years of laboratory or cGMP manufacturing experience.
Aseptic laboratory experience.
Basic knowledge of EHS, ISO, cGMP, and other manufacturing regulatory requirements.
Basic computer skills, familiarity with Microsoft Office applications.
Reliable and self-motivated.
Read, follow and understand test methods, operating procedures, and related documentation.

Responsibilities

Test products safely and in accordance with Standard Operating Procedures, Quality and Safety Specifications and GMP standards.
Safely set up and operate quality lab test equipment and monitor required inputs and outputs.
Support quality lab operations and projects under the supervision of senior technicians.
Accurately complete documentation per GMP standards.
Initiate and participate in Out of Specification (OOS) investigations.
Assist with execution of protocols, qualifications, and validations. Develop skills to independently perform Bacterial Retention Testing.
Ensure a clean and orderly workspace and have proactive identification of safety, quality, and productivity concerns. Actively report hazardous conditions or hazardous behaviors observed in the work center and the site.
Perform basic troubleshooting and test set-ups; review, verify, and accurately enter test and process data into the Laboratory Information Management System (LIMS); participate in sustainability efforts; and carry out assigned tasks under close supervision.