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Quality Specialist, Complaints job in West Point

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Merck & Co. jobs
Pennsylvania (PA), West Point
Job Code:  QUA007975
Employer:  Merck & Co.
Category:  QA

Country:  United States
State:  Pennsylvania (PA)
City:  West Point

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Complaint Quality Specialist is responsible for supporting complaint intake and providing oversight for the processing of consumer complaints. This will include but not be limited to accessing complaint records via a Trackwise system, verifying accuracy of complaint information and entry of complaint information into Trackwise as appropriate. Responsibilities will also include receipt and physical handling of returned consumer complaint samples. Perform trending and independent second person review for Annual Product Reviews or other trend request and support inspections/audits as needed. This role will also provide support to MMD (Merck Manufacturing Division) Adverse Event investigations as required.

Primary activities include but are not limited to:

• Intake of customer complaints received against finished products.
• Accessing complaint records in the Trackwise system daily.
• Verifying accuracy of complaint records and complaint codes for complaint records received at West Point (WP).
• Entry / update of complaints into the Trackwise database.
• Prepare complaint intake information for Complaint Investigators.
• Handling of returned customer complaint samples.
• Creating a Trackwise record for complaint samples that are returned to WP.
• Ensure sample chain of custody information in Trackwise is accurate.
• Ensure adherence to records retention requirements for returned complaint samples.
• Support compilation and analysis of PQC and AE data for Complaint Unit business processes.
• Run queries / reports from Trackwise system.
• Analyze query / report outputs and summarize in Annual Review assessments or memos for investigation support as needed.
• Generate and analyze Complaint Metrics.
• Update Standard Operating Procedures (SOPs) related to these business processes as needed.
• Identify need for corrective actions related to Product Quality Complaints.
• Perform and provide second person review for Adverse Event investigations
• Internal Audit and Regulatory Inspection support

Education Minimum Requirement:

• Bachelor's Degree (Bachelor's in Science field preferred)
Required Experience and Skills:

•3 years industry experience in Quality, Regulatory, or Pharmaceutical Manufacturing.
•Effective written and verbal communication skills.
•Ability to work independently and follow up on pending actions without being prompted.
•Strong aptitude with Microsoft Office applications, including Word, Excel and Outlook.
•Technical writing or investigation writing experience.
Preferred Experience and Skills:

•Experience working in Trackwise application.
•Demonstrated ability to analyze data, identify areas of concern and drive action.
•Experience with application of Lean Six Sigma / Merck Production System (MPS) principles and tools.
•Understanding of Product Quality Complaint (PQC) and Adverse Event investigation requirements for manufacturing sites.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
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