Lead Specialist, Laboratory Coe

**THE OPPORTUNITY**:
Our Quality teams 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.

This position is responsible to support initiatives to optimize laboratory systems, improve efficiency and productivity in quality laboratories.

**WHAT WILL YOU DO**:
Main responsibilities include:

- Maintains laboratory quality systems in accordance with cGMP and our quality guidelines.
- Leads lab system improvement and harmonization projects throughout all Quality Laboratories.
- Leads and supports initiatives in driving technology-enabled laboratory by developing technical and innovative solution to improve work efficiencies and productivities in quality laboratories.
- Maintains Laboratory Tier 4 matrix and Quality Risk Management risk register. Assists Lab COE manager to drive scorecard improvements.
- Develops and provides justifications for laboratory related capital projects.
- Provides technical coaching and guidance to Lab COE, senior/specialists and laboratory staff.
- Provide system administration and technical support/coordination of laboratory systems, including but not limited to LIMS, Empower, LabX, computerized and non-computerized lab equipment as well as systems maintenance related activities.
- Develop change control for lab equipment qualification, system development life cycle (SDLC) of computerized lab equipment and systems.
- Responsible for maintenance, improvement and harmonization of laboratory systems and procedures.
- Ensures the above activities are performed in accordance with cGMP, quality guidelines and all applicable regulatory guidelines.

**WHAT YOU MUST HAVE**
- Degree / Diploma in Science.
- B.Sc in Science, preferably Chemistry or Chemical Engineering with minimum 7 years’ experience in the pharmaceutical industries, or Diploma in Chemistry with minimum 8 years’ experience in the relevant industries/labs.
- Continuous improvement mindset.
- Good knowledge and understanding of GMP.
- Demonstrates the ability to develop and promote an environment that nurtures creativity and improvement of current ways of doing things.
- Demonstrates active skill in challenging the status quo, offering practical alternatives.
- Demonstrates the ability to actively seek opportunities for improving department processes and increasing efficiency.

**Leadership, Professional and Functional Competencies**:

- Previous On the Job Training (OJT) / Coaching skills is preferred
- Good understanding of Safety and cGMP practices
- Computer Literacy
- The experience in operating laboratory equipment and lab computer systems is very desirable
- Good oral and written communication and facilitation skills
- Other Personal Attributes: Self-motivated, Independent, Team Player, Highly Approachable, Meticulous

**WHAT YOU CAN EXPECT**
- Limitless opportunities across various areas in Manufacturing; well-structured career path
- A state-of-the-art facility that delivers solution to its customers world-wide

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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., Kenilworth, 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**

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.