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Specialist, Quality Assurance

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.

Description:

  • Review reportable external customer complaints,upon intake, for appropriateness for health authority submission
  • Document review/approval in complaint database
  • Collaborate with the Site Complaint Investigating Unit and MDCP -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.
  • Collaborate with Site Complaint Investigating Unit and MDCP TO to ensure robust corrective and/or preventive actions are put in place to address external customer complaints
  • Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
  • Collaborate with MDCP TO to update the Device Risk Management files, as needed.
  • Review and approve reportable external customer complaint investigation reports prior to their submission to health authority



Education Minimum Requirement:

  • BS in Engineering



Required Experience and Skills:

  • Minimum three (3) years experience in Pharma or Medical Device companies
  • Working knowledge of applicable medical device regulations, Risk Management Experience.
  • Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
  • A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
  • Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.



Preferred Experience and Skills:

  • Experience in Complaint Handling investigation process
  • Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements.)



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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck” in the United States, Canada & Puerto Rico. We are known as "MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

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.

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

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

EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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

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:
Not Specified

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):
Yes

Number of Openings:
1

Requisition ID:QUA008828

Specialist, Quality Assurance

West Point, NY
Full Time

Published on 08/24/2019