Senior Analyst, QC

Responsibilities

• Initiates deviation, investigations and MOC’s in Master Control. Acts as the department expert of Master Control and provides guidance to the team members on matters relating to MC


• Provides monthly review of the QC logbooks when appropriate and is responsible for the monthly scheduling of all QC team activities


• Authors and revises approved documents as required including SOPs, testing forms and MS forms. Complete GMP documentation, including testing forms, logbooks according to GDP


• Act as subject matter expert (SME) on QC internal release assays. Signature delegate for the AD-QC Operations in select matters


• Support the weekly environmental monitoring of the CPU’s facilities and the post sampling activities


• Reads, understands, and follows Standard Operating Procedures (SOPs)


• Actively involved in the training and mentoring of new hires


• Coordinates and schedules the maintenance of lab equipment with vendors. Submits work orders to facility for annual PM’s and calibrations performed on QC equipment by vendors


• Perform routine transactions with the ERP system including but not limited to material requisitions and submission of PRs for outside testing labs


• Able to perform procedures according to written guidelines and recognize a deviation from accepted practice


• May provide consultation on projects and is a high-level contributor/specialist. A wide degree of creativity and latitude is expected


• Participate in internal and external audits as required


• Compile and analyze data, prepare reports, and make recommendations for changes and/or improvements.


• Provide process development support when needed

Qualifications

• BS in Microbiology, Biology, Chemistry, or equivalent


• 7-10 years minimum years relevant experience


• Must be knowledgeable of various quality Control assays including flow cytometry and ELISA and have through knowledge of cGMP facilities and cGMP requirements


• Advanced knowledge of Microsoft applications, especially Word, Excel, etc.


• Strong organizational skills are required with the ability to manage and prioritize multiple projects or assignments at one time


• Must be able to exercise critical thinking and be able to troubleshoot when unexpected events occur


• Ability to exercise judgment within defined procedures and practices to determine appropriate action

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.