Senior Specialist QA Assistant

Position: Senior Specialist QA - I (Assistant)
Description:

Education/Experience Requirements

• Associate's degree in Biology, Microbiology, Biochemistry, or related field plus 1-2 years of relevant laboratory/pharmaceutical experience

• Bachelor's degree in Biology, Microbiology, Biochemistry, or related field

Required Experience and Skills

• Understanding and application of Good Laboratory Practices and cGMPs

• Aseptic technique

• Performance of environmental and water systems monitoring

• Working in a team environment

Preferred Experience and Skills

• Strong verbal and written communication skills

• Experience with LIMS, SAP or other laboratory/production software systems

Working Relationships

• Reports to Quality Control manager

• Interacts with employees within own department and other departments

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are ...
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

Additional Information
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.

Responsibilities
General

• Conducts release testing in support of finished product

• Conducts microbiological testing; evaluation of environmental microbiological samples

• Conducts environmental monitoring sampling to include active air and surface sampling and water sampling

• Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects

• Maintains lab materials and reagents
Business & Functional Expertise

• Completes assignments in alignment with department objectives

• Conducting In-Process and Release testing

• Conducting Environmental Monitoring of processes and on a routine basis

Problem Solving
o Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head

Impact
Influence
o Communicates information, asks questions and checks for understanding

Accountability
o Accountable for own performance

Decision Making
o Makes decisions - guided by policies and procedures - on the shop floor
o Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes
Enable Skills-Based Hiring No SAP Plant Code (Comet)
Additional Details

• Division :
  Merck Manufacturing Division (MMD)
• SAP Plant Code (Comet) : 3074;
  
  DHM;1570
• General Staffing / Professional Staffing :
  Professional
• Is Location Flexible? :
  No
• Is the Worker Onsite, Remote, or Hybrid? :
  Onsite