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Investigator, Lab Safety and Compliance Lead

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Sep 23, 2022

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Are you seeking an opportunity where you can grow your contributions to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this Investigator, Lab safety and Compliance lead role could be an exciting opportunity to explore.

This role will provide YOU the opportunity to contribute to analytical development and to progress YOUR career. Your responsibilities include some of the following:
  • Assist with authoring, review, approval, and lifecycle monitoring of departmental risk assessments.
  • Acts as system owner for various analytical equipment which includes system troubleshooting, authoring impact assessments and risk assessments, participating in analytical equipment validation lifecycle activities, such as executing change controls, and equipment management.
  • Create change controls and owns through the change control process, which may include presentation at change control meetings and circulation for approvals/closure.
  • Lead routine laboratory inspections and clean ups.
  • Communicates and enforces laboratory safety rules for GSK staff, vendors, contractors, and complementary workers working in the labs.
  • Lead appropriate safety training for lab users (i.e. yearly refresher or new starter general laboratory training, working with highly hazardous materials, chemical waste, etc.).
  • Track and trend incidents and non-injury events to minimize repeat events and ensure the safety and wellbeing of staff.
  • Participate in investigations for workplace incidents, conduct root cause analysis and propose corrective actions.
  • Manage departmental Management Monitoring Program, perform trending of observations, and work with stakeholders to remediate and implement improvements.
  • Act as Business Lead Investigator (BLI) for department GMP investigations and facilitate Root Cause Analysis to address deviations and propose/implement CAPA.
  • Documents work in accordance with GxP expectations, company policy, and legal requirements.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS in Chemistry, Biology or related discipline, with 7+ years in the Pharmaceutical industry.
  • Knowledge of GxP requirements, SOPs, analytical techniques, and practices used in pharmaceutical development.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience with analytical laboratory data systems.
  • Operational knowledge of laboratory equipment.
  • Knowledge of change control process.
  • Experience with lab safety and quality investigation.
  • Knowledge of risk assessment.
  • Excellent communication skills to collaborate with others within the group and across groups.
  • Strong technical writing skills for documentation.


Why GSK?

Uniting science, talent, and technology to get ahead of disease together

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​



With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​



Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​

GSKBiopharm_Development

*LI-GSK

#CMCDevelopmentGSK

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