Associate Specialist, Quality Control

MSD•Wilson, NC

4d•$65,100 - $102,500•Onsite

About The Position

This role involves performing routine assignments and developing competence through structured work. The Associate Specialist will use existing procedures for routine testing and will gain knowledge of fundamental laboratory instrumentation, theories, principles, and concepts. This position requires collaboration, seeking advice from others, and building team effectiveness by demonstrating respect for diverse perspectives. The individual will focus on understanding customer needs, seeking improvements in services, and expressing views constructively while encouraging team suggestions. Development of new skills, acceptance of performance feedback, and assisting team members are key aspects. The role also involves learning new problem-solving tools and applying general knowledge of the company's business. Interpretation of Quality Policies, Guidelines, and Testing Procedures, along with understanding and applying regulatory/compliance requirements like GMP and NDA, is essential. A basic knowledge of Quality Control discipline, pharmaceutical testing, and technical writing for investigations and procedures is expected. The ability to operate lab instrumentation, perform routine testing, and respond to data requests and trending is necessary. Communication, presentation skills (with assistance), and working within technical guidelines with limited decision-making authority are also part of the role. The Associate Specialist will be accountable for technical contributions and will require moderate to little supervision.

Requirements

B.A./B.S. degree (preferably in Science or Engineering)
Knowledge of continuous improvement principles.
Experience operating routine laboratory equipment including but not limited to: Karl Fisher, pH meter, conductivity meter, UV, etc.
Knowledge of regulatory and cGMP principles.
Adaptability
Analytical Instrumentation
Analytical Method Development
Analytical Problem Solving
Bioburden Testing
Chemical Analysis
Code of Federal Regulations
Corrective Action Management
Customer Service Improvement
Data Analysis
Karl Fischer Titrations
Laboratory Instrumentation
Laboratory Safety
Laboratory Techniques
Lab Testing Equipment
Microbiology Research
Performance Feedback
Pharmaceutical Testing
Quality Control Management
Quality Process Development
Regulatory Compliance
Service Improvement
Standard Operating Procedure (SOP)
Teamwork

Nice To Haves

Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
Experience utilizing Empower.
Experience utilizing GLIMS.
Execution of root cause analysis.
Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications.
Knowledge of Tier processes.
Experience executing 5S principals.

Responsibilities

Supports continuous improvement and sustainability of implemented changes, identifying and implementing continuous improvement changes within the laboratory.
Ensures work is completed right first time, participating in root cause and corrective action identification and documenting investigations.
Participates and leads, when required, Tier I and Tier II activities.
Demonstrates working knowledge of product performance and testing methodology.
Provides an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example.
Responds to and remediates audit observations.
Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs.
Participates in coordination of testing activities within work team.
Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, & finished pharmaceutical products.
Maintains compliance by following corporate policies/guidelines and local SOP's.
Interprets compendial and internal monographs, NDAs, and company Quality Standards.
Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD).
Assures laboratory compliance by adhering to cGMP, CFR, and other agency regulations.
Revises laboratory procedures as required.
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory.
Maintains 5S organization throughout the laboratory and identifies improvement opportunities.
Participates in project activities designed to improve the business operation of the laboratory, the compliance posture of the laboratory, the skills and capabilities of the laboratory, etc.
Performs any other work as assigned by Manager.