Junior Investigative Specialist

3+ months agoRockville, MD

Site Name: USA - Maryland - Rockville
Posted Date: May 7 2021

Are you energized by an opportunity to work with the latest manufacturing technology in a highly technical production environment? If so, this Operational Excellence role could be an ideal opportunity to explore.

  • Authors EM and PM notifications and assess product impact using inputs from various departments.
  • Assists in investigations including root cause analysis
  • Revision and management of manufacturing documents such as Batch Records and SOPs
  • Leads the rapid response for issues identified on the floor with completion of the incident form and supporting data as required to establish a path forward with area leadership & operational quality.
  • Initiates a Quality Notification as required following the rapid response and per the priority determine by quality. Transfer all collected investigative information to the owning specialist and support additional data capture 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 experience 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 authoring and/or revising technical documents
  • Experience with cGMP requirements and practices and previous experience in a cGMP setting
  • Technical writing skills (writing sample will be requested)
  • Experience supporting and/or lead system troubleshooting efforts
  • Experience working with cross-functional teams to solve production problems
  • Must be willing to work shifts
Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Advanced degree in Biology, Biochemistry or Chemical Engineering
  • Knowledge of cGMP requirements and practices and previous experience in a cGMP setting
  • Previous experience in a biopharmaceutical manufacturing facility (operations experience preferred)
  • Ability to work effectively cross-functionally, to solve production problems
  • Ability to support and/or lead system troubleshooting efforts
  • Participate in cross-functional teams to solve production problems
Why GSK?

Our values and expectations are 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
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