Associate Specialist, Quality Control

MSD • Wilson, NC

41d • 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, requiring knowledge of fundamental laboratory instrumentation, theories, principles, and concepts. The position involves receiving instruction and guidance, while also seeking advice on business issues. Building team effectiveness through respect and appreciation for diverse perspectives is key. The role requires understanding customer needs and seeking ways to improve services. Employees are encouraged to speak up on tough issues, express views, and encourage team members to make suggestions. Developing new skills, accepting performance feedback, and assisting team members are important. The role involves learning new problem-solving tools and applying general knowledge of the company business. Interpretation of the company's Quality Policies, Guidelines, and Testing Procedures for daily application is necessary. Understanding and applying regulatory/compliance requirements, including GMP, NDA, and related regulations, is crucial. A basic knowledge of theories, practices, and procedures in Quality Control, including pharmaceutical testing, is required. The role involves developing technical writing capabilities, compiling investigations and procedures, and recommending corrective actions. Basic knowledge and ability to operate lab instrumentation are needed for job responsibilities. Routine testing will be performed using existing procedures. The ability to independently respond to basic data requests and trending is expected. Communication of information and checking for understanding are important. Small-scale presentations to work teams or small groups, with assistance, will be developed. Decision-making authority is limited, and work is performed within technical guidelines to meet objectives and deadlines. The role is accountable for technical contributions and requires 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
• 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 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level