Associate Specialist, Operations

Merck•De Soto, KS

10h•$71,900 - $113,200•Onsite

About The Position

This role, in conjunction with the execution routine production activities, will primarily support the team by acting as a Subject Matter Expert (SME) representing their department in support of continuous improvement, problem solving and deviation and change management. Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Requirements

High School Diploma plus minimum four years working in a Pharmaceutical Manufacturing role
Adverse Event Reporting System
Autoclaving
Buffer Preparation
Cell Culture Process Development
Customer Service Operations
Detail-Oriented
Fermentation Process Development
Fermentation Tanks
Filtering Equipment
Liquid Chromatography (LC)
Media Preparation
Process Control
Production Scheduling
Safety Practices
Standard Operating Procedure (SOP) Writing

Nice To Haves

BS Degree in a relevant scientific discipline plus minimum one year working in a Pharmaceutical Manufacturing role

Responsibilities

Models Company leadership principles and inclusive behaviors.
Provides coaching and supports skills development and process capabilities within their team.
Supports effective feedback and coaching within the team during the Performance Management cycle.
May be responsible for providing appropriate task-based training.
Demonstrates a strong compliance mind-set (EHS and Quality) and continuously sets a high standard for themselves and others.
Follows safe operating instructions for all tasks and equipment.
Ensures that the right tools and equipment specified for the task are available and utilized.
Ensures that the correct personal protective equipment required is available and utilized.
To follow up any reported defects or workplace hazards immediately.
To report all accidents, incidents and near misses within 24 hours and to participate in investigation and identification of effective corrective and preventative actions.
Is responsible for the on-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.
Is responsible for all aspects of Quality Assurance including cGMP, RFT and good documentation practices and provides coaching to others.
Serves as Change Manager and Stakeholder for change management activities within Production.
Supports the update, review and approval of GMP documentation including, but not limited to: SOP’s, MD’s, Qualification Protocols, New product/product transfer documentation.
Supports the Daily, Weekly and Monthly schedule adherence of production activities within their department.
Build and maintain strong collaborations with different stakeholders throughout the Site Operations such as BTS, Engineering, Quality and R&D.
Supports the Manufacturing Operations Teams in creating a culture of continuous improvement and leads by example.
Represents Manufacturing Operations in the execution of the project portfolio and improvement initiatives.
Supports initiatives for stabilizing and improving production processes.
Assures effective application of Lean Six Sigma, Project Management and Change Management Tools.
Supports Manufacturing Operations key productivity metrics by investigating and solving operations issues with appropriate techniques and skills.
Contributing to a data driven decision making process and visualizing problems, progress and results.
Recognizes and investigates opportunities for financial savings.