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Qc Manager, Analytical Jobs

Company

ProKidney Corp.
Address Winston-Salem, NC, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-09-26
Posted at 8 months ago
Job Description
Description


  • Adapts departmental plans and priorities to address resource and operational challenges.
  • Qualified to perform all QC assays and help with trouble shooting as required.
  • Deliver to Plan: Lead and direct the safety, quality, and daily operation in QC. Oversee all tasks in the lab and clean rooms as they are carried out.
  • Reviews and approves QC testing forms.
  • Must have experience in writing technical documents and protocols.
  • Monitor and coach staff to ensure full compliance with GMP and Quality system requirements. Responsible for overall inspection readiness and compliance with quality requirements.
  • Manages QC analytical testing and personnel.
  • Subject matter expert of relevant QC assays.
  • Works with Product Development (PD) for the timely completion of required PD sample testing.
  • Lead and oversee the on-time completion of document review for completeness, clarity, accuracy to support on-time release of clinical lots.
  • Leads the stability testing program and raw material testing program.
  • Responsible for overall cGMP compliance of the department and may represent QC on project teams or during audits and inspections.
  • Able to clearly communicate problems and observations with management from other departments.
  • Maintain a good working relation with other departments.
  • Manages day to day operations and weekly testing schedule.


Requirements


  • 5+ years experience in QC analysis in a GMP environment required
  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
  • Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues.
  • Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills are a plus.
  • BS in Biochemistry, Biology, Chemistry, or equivalent required
  • Ability to exercise judgment within defined procedures and practices to determine appropriate action.
  • Subject matter expert in quality control assays including flow cytometry and ELISA.