Specialist, Data Services (Stability)

Job Description

Position Responsibilities:

• 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

Summary, Focus and Purpose

The QC Data Services 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 all stability management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other company's and third-party manufacturing and packaging sites. Assures compliance with FDA & GMP regulations. 

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Participate in development of objectives and ensures alignment with site goals

Development

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | 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 and quality events

• Timely approval of qualification, change control, procedures and other documents

• Demonstrates a deep 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 sites

• Support stability chamber audits, excursions, and improvement initiates

Information Transfer

• Attends departmental and team meetings focused on Stability program

• 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.

• Metrics review and reporting to Quality Council, etc.

• Generates/maintains stability technical agreements with other sites in network

Compliance

• Uses Root Cause Analysis tools to identify true root cause for quality and safety events

• Authors, reviews, approves and/or participates in quality investigations

• Participates in internal and external audits and inspections

• Identifies product-related data trends and facilitates implementation of corrective actions

• Creates/Revises Standard Operating Procedures, Forms and other documents

• Understands and applies regulatory / compliance 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 ≥ 4 years in a pharmaceutical laboratory setting

• Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical 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.