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Specialist, Incoming Quality

4 months ago

Durham, North Carolina, United States Merck Full time

Job Description
Our Quality Assurance team ensures all materials in our products are manufactured, tested, packaged, stored, and distributed to meet our high-quality standards and comply with regulatory requirements. Working with our manufacturing facilities, contract manufacturers, and suppliers, we have built a global manufacturing network focused on delivering quality supply to customers and patients worldwide.
Responsibilities of the Specialist include:

  • Sampling and inspecting raw materials/components for manufacturing support
  • Coordinating material sample analysis in internal and external labs
  • Reviewing and submitting testing results for materials
  • Supporting Operational Excellence Initiatives
  • Other Incoming Quality functions


The Specialist role involves:

  • Thorough and timely component inspection
  • Scheduling and coordinating testing for chemical samples
  • Developing SOPs for Incoming Quality processes
  • Contributing to investigations and documenting Quality Notifications and CAPAs
  • Supporting audits and inspections
  • Executing raw material sampling procedures for batch release
  • Backing site, divisional, and Quality initiatives
  • Providing support to Packaging Operations


Other responsibilities include:

  • Reviewing and approving SOPs
  • Supporting operational excellence initiatives
  • Understanding Compendial requirements for material testing
  • Performing duties as assigned


Education requirements:

  • B.S. or B.A. degree in Science or Engineering


Skills and experience required:

  • Minimum 2 years experience in pharmaceutical operations, technical services, and/or quality operations
  • Validation, Deviation, PM and Incoming Quality experience
  • Knowledge of Sampling plans, ANSI tables, and AQLs
  • Hands-on experience with SAP and LIMs preferred
  • BCG Production Medical Clearance


Preferred Skills and Experience:

  • Understanding of CFR, Eudralex, USP, and other pharmaceutical regulatory guidance


Physical Requirements:

  • Aseptic gowning ability
  • Ability to lift up to 25 lbs


Employees working in roles requiring collaboration with external stakeholders must comply with Company and external stakeholder policies. Vaccination against COVID-19 may be required for certain roles to access facilities or meet stakeholders.
US and Puerto Rico Residents Only:

US Hybrid Work Model
Effective September 5, 2023, U.S. office-based employees will follow a Hybrid work model, with three days on-site per week and one remote-working day. Field-based and certain other positions require in-person attendance. Remote work designation applies to specific roles.

*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.
Requisition ID:R292889