Team Leader, QC

CSL Plasma•Holly Springs, NC

1d•Onsite

About The Position

The Opportunity: To coordinate and ensure QC Microbiology team goals are achieved, and operational decisions made and accomplished promptly. Provide direction and coordination of all activities to ensure compliance with regulatory requirements and company SOPs. To ensure that all scheduling requirements are met, together with other departments where required. Mentor and develop staff technically and professionally. Supports efforts across multiple areas to accomplish goals, providing guidance and influencing the organization. Provide technical leadership and to co-ordinate the activities of work allocated to the team of analysts; specifically, the collection and testing of samples/raw materials, and support of validation studies. Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards.

Requirements

Bachelor’s degree in scientific discipline required or equivalent
Advanced ability to communicate technical knowledge
Minimum of 5 years’ experience in Quality Control testing techniques and industry practices
Direct experience with regulated environments (cGMP) and experience working in clean room environments
Knowledge of lab safety & data integrity
Experience within matrix / team environment
Experience with laboratory team scheduling
Experience serving as a laboratory SME and leading other team members through delegation and review of tasks
Experience in Track Wise, Veeva, GLIMS, and SAP
Experience with minor or major/complex investigations
Technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), sterility testing, growth promotion testing of microbiological media, identification of microbiological isolates, antimicrobial effectiveness testing, water and clean steam collection, gas sampling, environmental monitoring (EM) and EM trending.

Responsibilities

Ensure safety is always on the front line.
Schedule the activities of the team observing the Lean Lab solution; monitor and approve time and attendance; ensure training/competence completion; perform 1-1s and development planning; manage performance of all associates.
Monitor associated measurements being used to adapt plans accordingly.
Approve data generated from testing and to bring to the attention of the Team Manager and other site personnel test results and any trends, out of specification results. Also, perform the required transactions to release materials.
Ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards.
To ensure the use only of approved and validated test processes.
Co-coordinate department cGMP systems, such as deviation management, closure of corrective and preventative actions, change controls and SOPs.
Participate in improvement project teams where required driving quality decisions and provide advice and technical support where required.
Coordinate completion of any resulting activities.
Troubleshoot in the resolution of testing problems involving your team and customers/suppliers. Demonstrate within cGMP constraints and align with best practice.
Track the team ensuring that mandatory training is in place.
To encourage performance of staff through training, feedback every two months and development planning together with the Team Manager