Manufacturing Specialist (Investigative))

Site Name: USA - Maryland - Rockville
Posted Date: Nov 6 2019
Are you looking to have a direct influence on performance and product quality at our growing Biopharm manufacturing facility? If so, this Manufacturing Specialist (Investigative) role could be an ideal opportunity for you.

Job Responsibilities
Leads cross-functional deviation investigations with on-time closure to ensure product batch release.

  • Leads investigations including key responsibilities of:
  • Initiation and management of Quality Records
  • Root cause analysis
  • Product impact assessment
  • Stakeholder management
  • Develops, executes and oversees corrective action and preventive actions (CAPAs)

Works with the team to monitor critical process parameters
Leads or supports Continuous Improvement projects
Conducts data gathering, trending, and data presentation as needed to support investigations and continuous improvement activities
Supports Manufacturing coordination efforts such as sampling, equipment modification and maintenance, and internal inspection activities to ensure minimal interruption to routine operations
Assists with shutdown/changeover and campaign scheduling and schedule management
Supports Tech transfer and process monitoring support as needed
Support internal and external audits as needed
Revision and management of manufacturing documents such as Batch Records and SOPs as needed

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • BA / BS in a scientific or technical discipline, and 2+ years of demonstrated technical competency in biopharmaceutical manufacturing processing.
  • Previous experience in a biopharmaceutical manufacturing facility (operations experience preferred)
  • Previous experience in production control systems (Delta-V , CCDARTS, Unicorn, or similar)
  • Previous experience in process deviation investigations and remediation
  • Previous experience authoring and/or revising technical documents
  • Knowledge of cGMP requirements and practices and previous experience in a cGMP setting
  • Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget
  • Excellent communication and technical writing skills
  • Ability to support and/or lead system troubleshooting efforts
  • Initiates change control for equipment modifications
  • Assist in development, execution and reporting of data from biopharmaceutical technology and tech transfer studies/protocols
  • Participate in cross-functional teams to solve production problems
  • Ability to collect, assess, and generate and depict conclusions from large quantities of production data

Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*LI-GSK
GSKBiopharm_manufacturing

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