Our Quality Assurance 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 position of Senior Specialist in Quality Laboratory Support will be responsible for ensuring and maintaining high standards of quality and compliance within our organization. In this role, you will be responsible for all or subset of the key responsibilities below:

WHAT YOU WILL DO

Perform/review laboratory system lifecycle management, including risk-based approach system qualification/retirement for laboratory computerized systems, commissioning/decommissioning, system administration, periodic temperature mapping, and system periodic reviews, in accordance with approved procedures and standard lead time.
Lead CAPEX and asset settlement process to ensure accuracy and completion within stipulated timeline.
Lead and execute section and Quality improvement initiatives and other special projects, ensuring alignment with business goals and timelines.
Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with cross-functional teams and above-site functions. This includes initiating alignments proactively, sharing expertise, and providing input to ensure alignment and consistency across the organization.
Author/review Quality Notifications, lead root cause analysis and ensure effective implementation of related actions within the agreed timeframe.
Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency and compliance.
Identify opportunities and propose solutions to improve efficiency and compliance in processes, standards, and best practices within the team.
Provide leadership, expert guidance and support to team members, acting as a go-to resource for problem-solving and decision-making.
Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
Act as backup to Reporting Manager, assist in daily operations and strategized planning to ensure all business and compliance requirements are met within stipulated timeline.
Provides contractor oversight to support daily operations.
Support and respond to audit requirements and findings.
Any other duties as assigned by reporting manager.

WHAT YOU MUST HAVE

Essential

Degree in a relevant scientific or technical discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Science, Engineering, IT with GxP experience).
Minimum 6 years of applied professional work experience in Equipment Qualification and Computerized Systems Validation in a GMP-regulated environment.

Preferred

Strong knowledge of laboratory system lifecycle management, calibration & maintenance, Quality mindset and Data Integrity.
Work experience specifically in GMP regulated QC Laboratory or Lab Systems Support (e.g., LabX, Empower).
Demonstrated experience in change and project management with ability to lead a cross-functional team.
Experience in System Development Lifecycle (SDLC) and Lab equipment qualification (IQ/OQ) is preferred

Personal Qualities

Leadership skills and ability to influence/collaborate with stakeholders at various levels.
Customer focus with strong business acumen and continuous improvement mindset.
Strategic and critical thinking mindset with a collaborative and problem-solving attitude.
Strong communication and interpersonal skills.
Attention to detail and ability to prioritize tasks effectively at appropriate level.
Ability to work effectively in a team-based environment.

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., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, 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.

Senior Specialist, Quality Control