United States flag

Quality Systems Specialist I

米国 - カリフォルニア - サンタモニカ品質保証正社員
適用する

仕事内容

We are seeking a highly motivated individual who is a team player and has a mindset of growth, contribution, and continuous improvement to join us as a Quality Systems Specialist at Kite’s RDMC manufacturing site. The Quality Systems Specialist will ensure compliance with the Quality System’s procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

Responsibilities (Included but not limited to):

  • Supports and maintains Document Control Activities: (Scanning, Archival, Retrieval, Logbook issuance, Production Issuance and Verification).
  • Ensure Quality Systems conform to regulations and quality policies.
  • Ensure adherence to ALCOA principles
  • Support Quality Systems Governance for Quality Management Review.
  • Serve as site Subject Matter Expert (SME) for defined Quality Systems.
  • Develop, Coordinate, and lead Quality Systems governance & oversite meetings.
  • Engage with key stake holders and site leaders to ensure timely closure of Quality Actions.
  • Support quality assessments of internal operations to analyze compliance and assess risk.
  • Support all facility internal audits and regulatory inspections as needed.
  • Supports, develop and deliver technical and/or compliance training to Kite staff
  • Develop, Track and communication of site metrics to management.
  • Identify compliance and data integrity gaps across documentation quality systems.
  • Generate and revise standard operating procedures and associated documents as needed.
  • Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.

(This position may require flexibility and weekend/ holiday support)

Basic Qualifications:

  • MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR
  • BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product) OR
  • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product)

Preferred Qualifications:

  • 2+ years of working within Quality Systems.
  • Knowledge of Quality Systems and regulatory requirements.
  • Thorough knowledge of GMPs (21 CRF Part 11/210/211).
  • Understanding of Quality Systems, Deviation, CAPA, Change Control, Auditing practices/strategies.
  • Works on multiple assignments in collaboration with various department system owners.
  • Knowledge with aseptic manufacturing processes.
  • Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint as well as Adobe Acrobat.
  • Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Excellent interpersonal, verbal and written communication skills are meaningful in this collaborative work environment.
  • Proactive, detail-oriented and comfortable in a exciting environment with minimal direction and able to adjust workload based upon changing priorities.

Does this sound like you? If so, apply today!

#LI-ML1

#IND123