Lansdale, Pennsylvania

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 worldwide regulatory expectations.  Responsible for receipt, evaluation and proper handling of complaint samples to ensure they are sent to the appropriate site or contractor to ensure proper evaluation.  The complaints specialist may also be required to support receipt and handling of product quality complaints, as well as trending and reporting of global product quality complaints.  Provides knowledge and expertise on processes and systems for complaint-handling on an on-going basis to enhance existing processes.   

Main Activities:

  • Applies knowledge and experience to assigned responsibilities within product quality complaint management

  • As part of the team maintains awareness of evolving industry and regulatory trends associated with complaint management.

  • Applies knowledge to straightforward problems and builds knowledge of other areas.

  • Participates on cross-functional teams, as appropriate, focused on development of standard complaint management processes including investigations.

  • Works closely with business partners to assure complaint information is appropriately captured and transmitted.

  • Integrates different perspectives to assure team effectiveness.

  • Develop operating procedures for area to assure consistent processes among team.

  • May lead small departmental teams focused on improve effectiveness.

  • Makes decisions within guidelines and policies.

  • Contributes and adds to value of team goals.

Education Minimum Requirement: 

  • BS/MS in Life Science Field, Engineering Field or a related relevant discipline.  

Required Experience and Skills

  • Minimum of 3 years experience within the pharmaceutical industry. 

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

Preferred Experience and Skills: 

  • Requires established ability to manage time with competing priorities. 

  • Requires ability to identify and implement MPS principles and inclusive behaviors for continuous improvement. 

  • Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements.  

  • Ability to persuade others to solve straightforward problems.   

  • Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment. 

#NewCo

(320A70E3-C49D-58E8-9A72-6DFDEB101F29)

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:


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OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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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:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R85247

Lansdale, Pennsylvania

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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