Quality Control Microbiology Supervisor

GSK•Upper Merion Township, PA

21h

About The Position

This Quality Control Supervisor role involves providing front-line supervision to QC Scientists responsible for raw material, utility, in-process, and BDS testing, including weekend work. The role serves as a leader in testing and system optimization, driving continuous improvement, and participating in cross-functional collaboration. The position offers the opportunity to lead key activities such as ensuring timely and accurate microbiology testing, scheduling, maintaining compliance with internal and external standards, and ensuring laboratory personnel are qualified through proper training. It also involves establishing team objectives, coordinating resources, leading recruitment and performance management, reviewing and approving investigations and documentation, and troubleshooting laboratory test problems. The role may act as a point of contact for customers and utilize GPS tools for efficiency and problem-solving. Responsibilities include ensuring laboratories operate in a state of control and potentially serving as a subject matter expert for audits and inspections. This role requires working a shift that includes Saturdays and Sundays.

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.