Sr. Spclst, Quality Assurance

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.

**WHAT YOU WILL DO**

**Main Responsibilities include**:

- Primary Quality contact for IPT, day-day quality support/guidance to IPT
- Represent Quality in IPT Tiers and Governance meetings (act as liaison with central quality functions)
- New Product Introduction (NPI) - Quality Support for all NPIs (includes change control approval, material setup, etc.)
- Deviations/Events - Decision on IPT QN. Concur justification to proceed if required.
- Walkdowns/GEMBA in IPT
- Review/Approval for product specific documents - eg. PBS creation/revision, BOM memo, ER (in IPI), ECO (in SAP), MES, etc.
- Review/Approval of Alarm reports (QCA) for Utilities
- Review/Approval of PM extensions/Non routine maintenance and release
- Support activities of Cleaning development/validations/campaign length extensions
- Review/Approval of Process verification/validation protocols and reports
- Review/Approval of IPT Pest control reports
- Review/Approval of Sample Request for dispositioned materials (including SAP rundown transactions)
- Review/Approval of Management Review Reports for MDCP
- Provide Quality support for Non-Routine/Risk Release of Equipment/Utilities/Room
- Provide Audit Support (i.e. Audit backroom)
- Support ad hoc requests of Risk Processing/Bi-annual review
- Perform joint inspection for incoming damaged goods, review IMS vendor investigation reports
- Perform physical inspection for Rejected materials
- Perform any other tasks as assigned by Manager

**WHAT YOU MUST HAVE**

**Qualifications**
- Bachelor Degree in Science/ Life Science, Pharmacy, Pharmaceutical Science or Engineering.

**Experience**
- 7+ years of relevant experience in GMP manufacturing environment, preferably Quality Assurance

**Other Personal Attributes**:

- Good organization and time management skills.
- Able to work independently.
- Meticulous with high integrity.
- Good interpersonal and communication skills, with ability to work in cross-functional teams.
- Continuous improvement mindset.
- Positive attitude and self-motivated.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R238655