Associate Specialist, Quality Control

MSD • Wilson, NC

2d • Onsite

About The Position

This role involves performing routine assignments and developing competence through structured work, utilizing existing procedures for routine testing. It requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts. The position involves receiving instruction and guidance, seeking advice on business issues, and building team effectiveness through respect and appreciation for diverse perspectives. The individual will demonstrate an understanding of customer needs, seek ways to improve services, and express views constructively while encouraging team suggestions. Development of new skills, acceptance of performance feedback, and assisting team members are key. The role also involves learning new problem-solving tools and applying general business knowledge. Interpretation of Quality Policies, Guidelines, and Testing Procedures, along with understanding and applying regulatory/compliance requirements (GMP, NDA) are essential. A basic knowledge of Quality Control discipline, pharmaceutical testing, and technical writing for investigations and procedures is required. The ability to operate lab instrumentation, perform routine testing, and respond to data requests and trending is necessary. Communication, presentation skills (with assistance), limited decision-making authority within technical guidelines, and accountability for technical contributions with moderate to little supervision are expected.

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.

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
• annual bonus
• long-term incentive

What This Job Offers

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