Sr QC Specialist

Descripción del trabajo

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.  Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Sr QC Specialist, reporting to the Head of Quality Control Technical Services. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

Responsibilities:

• Acts as the Quality Control (QC) lead for Quality Management Systems (QMS) at the MVP-01 facility with a focus on managing Deviations, Investigations, Document life cycle, Corrective and Preventative Actions (CAPA), and Change Controls.
• Represent QC as Single Point of Contact (SPOC) for new software/technology implementation at the site level 
• Implement Risk Assessments for new and established technologies.
• Reviews and participates in instrument IOQ/PQ
• Monitor and trend Vector data to support method monitoring and improvements.

Additional job duties include:

• Take part in FMEA for new equipment.
• Active participant in Global QC software alignment and implementation. 
• Accountable for implementation of software templates
• Coordinate with Quality Control LIMS Administrator to implement batch to COA
• Must be able to think critically and demonstrate troubleshooting and problem-solving skills.
• Must be able to determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Facilitate Root Cause Analysis (DMAIC).
• Works with Regulatory & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented.

Basic Qualifications:

Master’s Degree and 4+ years of Biopharm experience

OR

Bachelor’s Degree and 6+ years of Biopharm experience

OR

High School Degree and 10+ years of Biopharm experience

Preferred Qualifications:

• Experience with Labvantage LIMS, Veeva, SoftMax Pro, and other quality systems.
• Strong working knowledge of cGMPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required
• Strong background in RCA and laboratory investigations
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.