Quality Control Microbiology Supervisor

GSK • King of Prussia, PA

1d

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Quality Control Supervisor role could be an exciting opportunity to explore. As Quality Control Microbiology Supervisor, you will provide front line supervision to QC Scientists, who are responsible for raw material, utility, in-process, and BDS testing which will also include weekends. Serves as a leader outside of their immediate role in regard to testing and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Accountable for microbiology testing related to utility, environmental monitoring, in-process, BDS, and raw material samples being performed on time and right first time. Includes scheduling and assurance of compliance to internal procedures and standards and external regulatory standards. Ensures laboratory personnel are qualified through proper training on appropriate departmental and site SOPs, training modules, GMPs, regulations, etc. Establishes laboratory team objectives, testing priorities, and coordinates laboratory resources to align with objectives and continuous improvement initiatives. Leads the recruitment, interviewing, and hiring process for laboratory staff. Facilitates performance management and supports the development objectives of your team. Reviews and approves investigations, change controls, protocols, and validation reports. Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Analytical Methods and Specifications and troubleshoots laboratory test problems. May serve as point of contact for internal and external customers for testing. Utilizes GPS tools and processes to continuously improve efficiency and assist with problem solving. Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP’s, GMP’s and regulations and may serve as SME for internal and external regulatory audits and inspections. This role will be required to work a shift that includes Saturday and Sunday.

Requirements

• Bachelors in biology/microbiology or related science
• 5+ years' experience in a GxP regulated laboratory environment
• 5+ years’ experience in Microbiology
• 2+ years of supervisory experience

Nice To Haves

• M.S. in Biology/Microbiology or related science
• Demonstrated supervisory and leadership skills
• Strong interpersonal and leadership skills.
• Solid team player able to function within team-based organization.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
• Able to prioritize and decide appropriate course of actions.
• Effective at implementing decisions
• Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.

Responsibilities

• Accountable for microbiology testing related to utility, environmental monitoring, in-process, BDS, and raw material samples being performed on time and right first time. Includes scheduling and assurance of compliance to internal procedures and standards and external regulatory standards.
• Ensures laboratory personnel are qualified through proper training on appropriate departmental and site SOPs, training modules, GMPs, regulations, etc.
• Establishes laboratory team objectives, testing priorities, and coordinates laboratory resources to align with objectives and continuous improvement initiatives.
• Leads the recruitment, interviewing, and hiring process for laboratory staff.
• Facilitates performance management and supports the development objectives of your team.
• Reviews and approves investigations, change controls, protocols, and validation reports.
• Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Analytical Methods and Specifications and troubleshoots laboratory test problems.
• May serve as point of contact for internal and external customers for testing.
• Utilizes GPS tools and processes to continuously improve efficiency and assist with problem solving.
• Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP’s, GMP’s and regulations and may serve as SME for internal and external regulatory audits and inspections.

Benefits

• You will join a global company focused on science and technology to improve health.
• You will get opportunities to learn, grow, and take on meaningful work.
• We support an inclusive culture where different perspectives matter.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level