Senior Specialist Quality Control

MSD•Upper Gwynedd Township, PA

1d•$106,200 - $167,200•Onsite

About The Position

The Senior Specialist, WPLO Equipment Support Group (ESG) Senior Specialist IPT Lead is responsible for the implementation, life cycle management, and administration of laboratory equipment utilized within assigned areas of Laboratory Operations. Responsibilities include providing technical expertise to support run the business daily activities, leveraging the RBAM (Risk Based Asset Management) process to assess high/medium risk equipment, collaborating with the Small Capital POC to work on forecasts to align funds for future risk mitigation, leading projects, implementing operational improvements, supporting and/or having oversight over instrument qualification and implementation, and decommissioning. The ESG Senior Specialist IPT Lead is responsible for being the single point of contact for their assigned IPT Lab areas and is accountable to ensure strong Customer Focus and support.

Requirements

Bachelor’s degree in: life sciences, scientific discipline, engineering or business required.
For candidates with Bachelor’s degree, a minimum of 4 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operation, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in laboratory, manufacturing, science related or regulated field.
For candidates with Master’s degree, a minimum of 2 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operation, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in laboratory, manufacturing, science related or regulated field.
Adaptability
Coaching
Competency Development
Competency Management
Corrective Action Management
Customer Centricity
Customer-Focused
Decision Making
Detail-Oriented
Equipment Ordering
Forensic Chemistry
Good Manufacturing Practices (GMP)
Laboratory Operations
Life Cycle Planning
Logical Thinking
Overcome Obstacles
Product Ordering
Quality Standards
Regulatory Management
Root Cause Analysis (RCA)
Root Cause Identification
Root Cause Investigations
Service Contracts
Task Allocation

Nice To Haves

MPS experience - 8–step Problem Solving.
Demonstrated experience with root cause analysis tools.
Demonstrated quality decision making.
Self-starter with capability to develop innovative solutions and challenges.
Proven analytical aptitude, critical thinking skills and ability to apply key concepts.
Speaks with courage and candor.
Strong written and verbal communication skills.
Project management experience.

Responsibilities

Act as the primary facilitator to coordinate the IPT projects in respect to assigned Lab areas.
Function as the liaison between ESG IPT and IPT Lab Leads to focus on customers' demands.
Ensure work is prioritized and provide visibility of obstacles for project completion and timelines to Lab Leads.
Attend the Lab Lead Tier meetings to ensure continuous and clear communication.
Qualify, implement, manage and decommission equipment.
Create PMs and actively update calibration and equipment databases as necessary.
Author SDLC documentation.
Initiate Deviation reports and provide assistance to Deviation Management with associated investigations.
Identify and assist in the implementation of Corrective and Preventative actions to support reoccurrence of atypical events.
Facilitate cross functional meetings for equipment implementation as needed.
Works directly with the Equipment, Maintenance and Utilities team to prioritize and schedule preventative and corrective maintenance.
Complete parts purchase orders as needed.
Assist with service contract negotiations with associated vendors.
Provide coaching and guidance to new personnel and Quality Specialists.
Provide support to Regulatory Agency inspections as needed and author or support writing response reports as necessary.
Help facilitate training and work assignments for contractors assigned to that specific ESG IPT area.
Ability to Lead a project across multiple workstreams.