Organon - Complaints Associate Specialist

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:

Responsible for executing Product Quality Complaint policy and guidance to assure OMS product quality complaint management processes are in compliance with regulatory expectations.

Responsible for receipt and handling of product quality complaints for US marketed products.

Ensures accurate, consistent and timely entry of product complaint related details into electronic tracking system.

Interfaces with Site Investigating Units (SIU) to ensure receipt of information, address follow-up questions and closure of complaints when required.

Manages the intake of complaint samples for the US market. Identifies appropriate investigating site, documents sample information and prepares sample for shipment to investigating site. Performs functional testings, when designated by SIU, documenting all findings in the complaint records.

Ensures objectives are aligned with company, divisional, stakeholder and overall business objectives.

Education Minimum Requirement:

HS Diploma with strong computer skills.

BS in Life Science Field, Engineering Field or a related relevant discipline

Required Experience and Skills:

Strong preference for previous quality / compliance experience, and previous complaint experience.

Leadership:

Requires established ability to manage time and personal/group effort. Strong demonstrated interpersonal, communication, collaboration and leadership skills. Solid problem solving and decision making abilities with attention to detail. Word processing and spreadsheet/database skills are desirable.

#NewCo

(60051142)

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com