Associate Specialist, Operations

Merck•De Soto, KS

1d•Hybrid

About The Position

The Operations Associate Specialist, 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, transfer of new products, problem solving, as well as deviation and change management. The basic purpose of this position is to provide expert support for our Company Animal Health antigen production operations at our site in De Soto, Kansas. This position provides technical and operations support to assure that manufacturing schedules are met in a compliant manner with safety, quality, and regulatory requirements. Responsibilities include that antigen products specifications are met prior to release for compliance to product Outlines, United States Department of Agriculture 9 Code of Federal Regulations, and cGMP. The scope of support includes every manufacturing stage from raw materials through final antigen product.

Requirements

High School Diploma plus three (3)+ years of experience working in a Pharmaceutical Manufacturing role.
Adverse Event Reporting System
Adverse Event Reporting System
Autoclaving
Buffer Preparation
Cell Culture Process Development
Change Management
Collaborative Development
Customer Service Operations
Detail-Oriented
Driving Continuous Improvement
Fermentation Process Development
Fermentation Tanks
Filtering Equipment
Global Manufacturing
GMP Compliance
Liquid Chromatography (LC)
Media Preparation
Monoclonal Antibodies
Operations Support
Pharmaceutical Manufacturing
Polyclonal Antibody Production
Process Control
Production Scheduling
Quality Assurance (QA)
Recruitment Operations

Nice To Haves

BSc Degree in a relevant scientific discipline plus experience working within 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
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
Follow up any reported defects or workplace hazards immediately
Report all accidents, incidents and near misses within 24 hours and to participate in investigation and identification of effective corrective and preventative actions
On-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.
Quality Assurance including cGMP, RFT and good documentation practices and provides coaching to others.
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