Associate Specialist, Quality Control

Merck•Wilson, NC

3d•$65,100 - $102,500•Onsite

About The Position

This position is for an Associate Specialist in Quality Control. The role involves performing routine assignments and developing competence through structured work. The individual will use existing procedures for routine testing and will gain knowledge of laboratory instrumentation, theories, principles, and concepts. The role requires seeking advice when addressing business issues and promoting team effectiveness by respecting diverse perspectives. The individual will demonstrate an understanding of customer needs and seek ways to improve services. They will be encouraged to speak up on tough issues, express views and ideas, and encourage team members to make suggestions. The role involves developing new skills, readily accepting performance feedback, assisting team members, and learning new problem-solving tools. The individual will apply general knowledge of the company's business and interpret Quality Policies, Guidelines, and Testing Procedures. Understanding and applying regulatory/compliance requirements, including GMP, NDA, and related regulations, is essential. The role requires a basic knowledge of Quality Control discipline, including pharmaceutical testing. Technical writing capabilities will be developed, enabling the compilation of straightforward investigations and procedures, and recommending corrective actions. Basic knowledge and ability to operate lab instrumentation are required. The individual will use existing procedures for routine testing and independently respond to basic requests for data and trending. Communication skills are important, including checking for understanding. The role involves developing small-scale presentations with assistance. Decision-making authority is limited, and the individual will work within technical guidelines to achieve objectives and meet deadlines, being accountable for technical contributions. Moderate to little supervision is required.

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
Analytical Testing
Business Functions
Chemical Analysis
Detail-Oriented
GMP Compliance
GMP Laboratory
Laboratory Information Management System (LIMS)
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 supports sustainability of implemented changes. Identifies and implements continuous improvement changes within the laboratory.
Ensures work is completed right first time. Participates in root cause and corrective action identification and documents 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.