3270 QC Analyst I

Summary:
Perform testing and related work in the Product Analytical and Bioassay Testing (PABT) organization on in-process, drug substance, and drug products for release or stability programs.
Perform laboratory testing in a cGMP environment and understand the science and compliance needs of the business.
Actively participate in continuous improvement to maintain company’s right to operate, supply to patients and cost effectiveness.

Job Responsibilities:
Leadership:
Create an environment of strong team spirit with timely and effective communications.
Be an active and visible change agent.
Establish strategic goals and objectives for the department.

Technical:
Perform a broad variety of basic and moderate complex tests in support of lab operations.
Perform testing of routine and non-routine samples and documents according to cGMPs.
Perform routine lab maintenance.
Prepare basic and complex reagents as assigned.
Independently manage competing priorities with limited instruction.
Identify and recommend solutions to potential procedural, process system gaps.
Receive and provide training.
Participate in assay transfer and assay validation.
Perform equipment qualification/maintenance.
Coordinate with customers to support operational activities.
Maintain a state of inspection readiness.
Actively participate in group and project teamwork; project and process improvements.
Resolve issues as needed with management approval.
Adhere to cGMP policies and procedures, including documentation activities.
Meets scheduled performance of 95% on time.
Perform other duties as requested by supervisor/manager to support Quality.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.