Senior QA Technical Complaint Specialist

Posted 11 Mar 2020

Rockland, Massachusetts - United States

Req Id 204304


A career with EMD Serono is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

To ensure that EMD Serono US is compliant with cGMP, US Regulatory and Healthcare Quality Standards for Technical Complaint Handling

To accurately capture detailed information related to EMD Serono Product and Device complaints to support effective investigation

To ensure regulatory inspection readiness by processing and maintaining complete and accurate records required.

To communicate complaints to the respective affiliate QA responsible for investigation

Process product complaints in accordance with SOPs, including:

  • Telephone contact with customers
  • Documenting details of the complaint in TrackWise (i.e., Product name, lot number, nature of the complaint)
  • Obtaining customer information
  • Prepare initial narrative report of the information received and communicate to respective manufacturing sites
  • Determine if the complaint is Medical or Technical in nature. If Medical in nature, communicating the details to USPS
  • Facilitate return of Product reported from the complainant for further investigation
  • Process returned goods receipt data entry of returned products into EMD Serono’s inventory management systems and expedite inspection process
  • Perform visual inspection, where required, of returned samples and document findings in TrackWise, and forward visual inspection summary to manufacturing QA in a timely manner
  • Coordinate the replacement of Product or Medical Device to customer’s Pharmacy where required, with special attention to the time sensitivity associated with EMD Serono Products
  • Receive and review manufacturing QA close out reports for accuracy and completeness. If the information is incorrect or incomplete, follow up with manufacturing QA to resolve
  • Update records in TrackWise to indicate complaint closure when all documentation is complete and in order
  • Prepare monthly or ad hoc queries or summaries by product and nature of complaints to determine if there is evidence of positive or negative trends developing locally
  • Archive files and documentation as required
  • Work with various call center personnel to ensure customers are transferred quickly and their needs are addressed appropriately


Who you are:

Minimum Qualifications:

  • Bachelor’s degree in Chemistry, Biology or other science or business discipline
  • 1+ years’ experience related to customer service, direct customer contact or call center operations, preferably specific to Product Complaint Handling.


Preferred Qualifications:

  • 1+ years’ QA experience within pharmaceutical or biotech industry
  • High level of professionalism and interpersonal skills
  • Proficiency with various computer software application, i.e., MS Office, TrackWise experience a plus
  • Outstanding attention to detail
  • Knowledge of GxP requirements related to drugs, biologics, device regulations and regulatory / FDA compliance



What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.


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