Associate Specialist, Data Services (Stability) Position Available In Wilson, North Carolina

Associate Specialist, Data Services (Stability)
Associate Specialist, Data Services (Stability)
remote type
Not Applicable
locations
USA – North Carolina – Wilson
time type
Full time
posted on
Posted 10 Days Ago
time left to apply

End Date:

May 15, 2025 (3 days left to apply)
job requisition id
R347328
Job Description

Position Responsibilities:

We are seeking a Growth and Improvement minded Data Services Associate 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 aremitted to providing an inclusive and weing 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
Summary, Focus and Purpose
The QC Data Services Associate Specialist is responsible for NASU Stability program management, stability plan maintenance, coordination of monthly stability pulls and delivery, and support of stability related change controls, Quality Notifications and CAPAs. They demonstrate proficiency with stability management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other of our and third-party manufacturing and packaging sites. Assurespliance with

FDA & GMP

regulations. Key Functions
Development Work Independently and as a Team member with Integrity | Precision | Aplishment | Motivational Ambition | Respect | Inclusion
Participate in development of objectives and ensures alignment with site goals
Laboratory Support
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 related to safety, quality and downtime events.
Timely approval of qualification, change control, procedures and other documents.
Demonstrates an understanding of customer needs, requirements, and expectations.
Coordinates stability sample pulls and delivery to labs per defined scheduled intervals.
Set up international shipments for product to our Company sites.
Support stability chamber audits, excursions, and improvement initiates.
Information Transfer
Attends departmental and team meetings focused on the Stability program.
Serves as liaison between NASU teams, Leadership, and External Vendors. Ability to interpret our Company Quality Policies and Guidelines for daily application. Participates in Tier Meetings.
Promotes teamwork and open discussion of issues.
Compliance
Uses Root Cause Analysis tools to identify true root cause for quality and safety events.
Participates in quality investigations as needed.
Participates in internal and external audits and inspections.
Creates/Revises Standard Operating Procedures, Forms and other Stability related documents.
Understands and applies regulatory /pliance requirements, including GMP, NDA, and related regulations, and can interpret those regulations for implementation in the workplace.
Minimum Requirements
Associate degree, preferably in Science with ≥ 2 years in a pharmaceutical laboratory setting; or
Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with some experience in a laboratory setting
Preferred Experience and Skills
Ability to quickly learn new processes and procedures.
Experience working within a pharmaceutical Stability program.
Experience working with multiple sites and/or third-party vendors.
Working knowledge of GMP’s, Government regulations.
Good technical writing skills.
Some experience in audit scenarios.