QC Sampling Specialist

Merck•Indianapolis, IN

4d•Onsite

About The Position

In this role you are responsible for the sampling of active materials, functional excipients, excipients and other materials and the sampling program around those incoming materials at the Indianapolis site. The individual will execute the program according to standard operating procedures and comply with cGMP and safety regulations.

Requirements

Associate's Degree in Biology, Microbiology, or other Life Science discipline and 2+ years of experience in sampling, laboratory, aseptic, or quality roles in the pharmaceutical industry.
OR High School Diploma or GED and 4+ years of experience in sampling, laboratory, aseptic, or quality roles in the pharmaceutical industry.

Nice To Haves

Experience working in an aseptic controlled area.
Experience in a fast-paced environment while maintaining attention to detail.
Experience with SAP.
Strong verbal and written communication skills.
Excellent knowledge of cGMP.
Excellent interpersonal and teamwork skills.

Responsibilities

Sample material according to plan without contamination.
Fill out appropriate documentation and adjust inventory in SAP.
Coordinate with manufacturing, supply chain, and/or other departments to ensure sampling occurs according to schedule.
Ensure sampling procedures and training documents are correct and describe the sampling operations accurately.
Interact with regulatory agencies such as FDA and clients to explain sampling processes.
Training backup technicians on sampling duties.
Perform all sampling duties safely including maintaining tools, equipment and sampling areas in excellent condition.
Maintain samples in correct containers and in appropriate conditions to ensure sample integrity.
Keep management informed of any sampling problems in a timely manner.
Perform special projects and assist in other Quality Control duties.