Job Description

Primary Responsibilities

Primary activities include, but are not limited to:

• Ensure accurate, consistent, and timely entry of product complaint–related data into the electronic tracking system.
• Compile and distribute monthly Product Quality Complaint (PQC) trending reports in alignment with the Global Annual Complaint Trending Plan, and address any follow-up queries.
• Collaborate with Site Investigating Units (CIUs) to ensure timely receipt of required information, respond to follow-up questions, and support complaint closure activities.
• Align individual objectives with company, divisional, stakeholder, and overall business goals.
• Coordinate complaint documentation and ensure sample availability, and communicate effectively with the Complaints Investigation Unit (CIU).
• Monitor, track, and ensure adherence to complaint-related Key Performance Indicators (KPIs).
• Participate in cross-functional meetings and discussions involving sites and DPOCs.
• Manage the complaint mailbox end-to-end, including triaging incoming records for appropriate processing.
• Complete all assigned training activities within the required timelines.
• Raise extension requests for overdue cases and ensure timely delay notifications where applicable.
• Draft or coordinate responses to customers or Health Authorities following completion of investigations.
• Perform additional tasks as assigned or required by management.

Education, Skills & Experience

Qualifications

• Bachelor’s degree in Pharmacy (B. Pharma)

Required Experience & Skills

• Prior experience in product complaint handling and/or adverse event investigation
• Working knowledge of Quality Systems and Quality Assurance processes
• Experience in pharmaceutical manufacturing and/or biological/sterile products

Preferred Experience & Skills

• Knowledge of external manufacturing management, supply chain, and operations
• Ability to collaborate effectively across internal and external stakeholders
• Strong problem-solving skills with a continuous improvement mindset
• Six Sigma certification (preferred)

Required Skills:

Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, Business Management, cGMP Compliance, Complaint Management, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI), Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Pharmaceutical Systems, Quality Assurance Processes, Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Stakeholder Management, Supply Change Management, Supply Management, Technical Writing {+ 2 more}

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.