Job Description

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.

Position Responsibilities:

* Manages water laboratory operations including personnel, sample flow, equipment, test methods, Standard Operating Procedures (SOPs), automation, deviations and other associated laboratory elements.

* Ensures test data is accurate and all work is Right-First-Time. Works closely with laboratory team members to ensure the highest levels of Good Manufacturing Practice (GMP) compliance and inspection readiness.

* Ensures test methods are compliant with standards, registrations, and compendia.

* Performs second person review for analytical data such as Conductivity, Bacterial Endotoxin Test, Bioburden, and other microbiological and chemical tests on a variety of water and production samples.

* Ensures inspection readiness and interacts with regulatory inspectors as needed.

* Capable of interacting with and understanding various data acquisition/management software and Laboratory Information Management Systems (LIMS).

* Routinely participates in laboratory related activities such as second person review, validation, qualification, report writing, deviation investigations, training, and others.

* Support change control, deviation management and compendial assessments as necessary.

Education Minimum Requirement:

* Bachelors in Microbiology, Biology, Biochemistry or other relevant discipline.

Required Experience and Skills:

* Applicant must be able to work independently in an open and diverse team environment.

* Time management and strong communication skills.

* Strong problem solving awnd laboratory-related software application skills.

* A minimum of 3 years pharmaceutical experience.

* 5 years industry experience

Preferred Experience and Skills:

* Experience with SAP, Track-Wise, LIMS. Pharmaceutical testing experience.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats 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., 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.

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:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R106373