Associate Specialist, Quality Control

MSD•Wilson, NC

3d•$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 apply fundamental laboratory instrumentation, theories, principles, and concepts. The position requires seeking advice and information from others, building team effectiveness through respect and appreciation for diverse perspectives, and demonstrating an understanding of customer needs. The individual will be encouraged to speak up on tough issues, express views and ideas, and encourage team members to make suggestions. Development of new skills and abilities, acceptance of performance feedback, and assisting other team members are key aspects of this role. The Associate Specialist will learn to use new problem-solving tools and apply general knowledge of the company business. Interpretation of the company's Quality Policies, Guidelines, and Testing Procedures for daily application is essential. Understanding and applying regulatory/compliance requirements, including GMP, NDA, and related regulations, is crucial. The role requires a basic knowledge of theories, practices, and procedures in Quality Control, including pharmaceutical testing. Developing technical writing capabilities to compile straightforward investigations and procedures, and recommend corrective actions, is also part of the role. The Associate Specialist will possess basic knowledge and ability to operate lab instrumentation, use existing procedures for routine testing, and independently respond to basic requests for data and trending. Communication of information and asking questions to check for understanding are important. Small-scale presentations to work teams or small groups, with assistance, will be developed. Decision-making authority is limited, and the role operates within technical guidelines to achieve objectives and meet deadlines, contributing technically to work or project teams with 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.
Analytical Testing
Business Functions
Chemical Analysis
Detail-Oriented
GMP Compliance
GMP Laboratory
Lab Testing Equipment
Nondestructive Testing (NDT)
pH Measurement
Preventive Action
Quality Control Inspection
Quality Control Management
Quality Engineering
Quality Improvement Programs
Quality Process Development
Quality Standards
Raw Materials
Regulatory Compliance
Standard Operating Procedure (SOP)
Standards Compliance
Statistical Data Analysis
Teamwork
Technical Support

Nice To Haves

Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
Experience utilizing Empower.
Experience utilizing Labware 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 any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, & finished pharmaceutical products.
Maintains compliance by following corporate policies/guidelines and local SOP's.
Interprets compendia! and internal monographs, NDAs, and our company's 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.