Investigator

Are you a Microbiology Professional looking for a challenging opportunity provide oversight of quality control support for R&D GMP manufacturing operations, while driving process improvements and simplification? If so, this could be a great position to explore.

As an Investigator in Microbiology, Systems, and Analytical Services (MSAS), you will be responsible for ensuring testing is performed by MSAS per applicable standards, reporting and investigating aberrant data and helping to resolve technical issues as they arise, driving both compliance and efficiency. In addition, you will be responsible for maintaining GMP documentation, writing and revising GMP documents, and ensuring compliance with global standards.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Key Responsibilities:

• Provides oversight of the on-site contract Microbiology/Pilot Plant Support testing teams, with accountability to the GSK Microbiology Team Leader, including collaboration with other GSK team members
  
• Responsible for ensuring the progression of facility and product testing/qualifications within designated timelines, ensuring all work performed in the team is carried out in accordance with applicable standards (cGMP and Safety)
  
• Communicates to Team Leader and other GSK Microbiologists investigations of aberrant microbiological test results or trends
  
• Supports and helps solve laboratory investigations
  
• First point of contact with the R&D Manufacturing Operations team for sample submission and testing
  
• Review, prepare and approve SOPs, methods and data as applicable
  
• Reviews/approves facility Performance Qualifications and ensures completion of the testing
  
• Monitors data/responds to alarms and performs investigations from group-owned online critical utility monitoring equipment
  
• Participates in Audit prep and support
  
• Oversees monthly Data Audits of the contract team, including action completion
  
• Develop improvements in training for the contractors by participating in laboratory GEMBAs
  

Why you?

Basic Qualifications:

• Bachelor's degree in Microbiology, Biology or related majors
  
• Minimum of 7 years of practical cGMP laboratory experience
  
• Experience with cGMP requirements
  
• Experience with Bioburden and/or Endotoxin testing
  
• Experience environmental monitoring
  

Preferred Qualifications:

• Ability to generate high quality data
  
• Supervisory experience a plus
  
• Has good working knowledge of microbiological methods and technologies.
  
• Excellent team-working and communication skills (at all levels of the organization such as peers, customers, and senior managers). This includes networking across key business units and building strong collaborations with key business partners.
  

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, rigor 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
  

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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