Quality Control Specialist

MSD•Wilson, NC

1d•Onsite

About The Position

We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities. Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business) Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us. The QC Data Services Specialist is responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs. They demonstrate mastery of all data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other company divisions and third-party manufacturing and packaging sites. Assures compliance with FDA & GMP regulations. Demonstrates the ability to influence a team (including Global Support and Outside Organizations) and is a recognized resource to others.

Requirements

Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting
Prior experience in a pharmaceutical laboratory setting.
Knowledge and experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)
Adaptability
Analytical Instrumentation
Analytical Method Development
Dissolution Testing
Driving Continuous Improvement
GMP Compliance
Karl Fischer Titrations
Laboratory Documentation
Laboratory Safety
Microbiological Analysis
Microbiological Test
Teamwork
Technical Writing
Troubleshooting
Use of Laboratory Equipment

Responsibilities

Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence, reduce laboratory downtime and increase reliability
Following standard work for escalation as it relates to safety and quality events
Timely approval of qualification, change control, procedures and other documents
Demonstrates a deep understanding of customer needs, requirements, and expectations
Performs stability and plant site release and study approvals
Supports GLIMS updates; reviews builds, IPI specification verification
Review of technical memos and testing protocols
Attends departmental and team meetings focused on Stability data review and reporting
Serves as liaison between NASU teams, Leadership, and External Entities
Ability to interpret our Company Quality Policies and Guidelines for daily application.
Participates and/or Directs Tier Meetings
Promotes teamwork and open discussion of issues.
Statistical summary analysis for manufacturing site Annual Product Reviews (APR)