Senior Specialist, AH Quality Technology

Job Description

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.

Labware LIMS Business support

• Performs Global LIMS technical updates as needed and supports projects.

• Support the Labware global roll out as agreed with quality leadership

• Partner with the functional areas, supporting the Global business process in the LIMS system.

• Contribute to the development of site SMEs and peers.

• Understand critical actions and challenges in LIMS and ensures these are adequately handled at the sites.

• Help to ensure permanent inspection readiness for LIMS processes.

• Ensure that the validated status of global LIMS is maintained throughout the system's life.

• Primary contact for site Admins in case of errors, problems, best practices and requests for LIMS.

• Support and assist upper management to visualize their needs on KPI and dashboards from LIMS.

• Support the LIMS advancement in alignment with upper management such as interfaces, ELN, calibration, etc.

• Share and communicate LIMS knowledge

• Maintain global static data and assist with queries.

LIMS System Maintenance:

• Review system issues and ensure they are escalated as appropriate.

• Configure calculations and subroutines to meet business needs’

• Contribute to the global LIMS SOPs and Training modules.

• Ensure global training and global SOPs are updated based on change request implementation.

• Elicit change requests from site teams and engage the community in priority setting

• Oversee the progress of change requests, tickets and projects

Education Minimum Requirement:

• Bachelor's or Academic degree in an appropriate Scientific, Engineering, Quality or Compliance, or related areas of study.

Required Experience and Skills:

• At least five (5)years of work experience and a demonstrated track record with configuration of Labware LIMS in a pharmaceutical, biologics and/or vaccine manufacturing environment or a similarly regulated field'

• Strong Quality Mindset and quality/compliance background

• Sufficient manufacturing/laboratory background to understand business challenges

• Ability to communicate with and to deliver training to the user community

• Ability to manage multiple priorities in a fast-paced environment

• Proven organizational and time management skills.

• Project Management Skills; able to manage complex processes.

• Excellent Communication

• Fluency in English (Speaking and writing)

Preferred Experience and Skills:

• Ability to work within a matrix organization to align on expectations and resolutions.

• Fluency in German

This position may be Remote

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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R119468