(858) 412-4156

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Position: Manager/Senior Manager/Associated Director of CMC QA

Level dependent on experience

Essential Duties and Responsibilities

  • Support the development, implementation, and improvement of company quality systems
  • Promote a culture of quality throughout the company and, increase compliance awareness with a focus on laboratory and manufacturing operations
  • Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
  • Write, review and revise standard operating procedures
  • Review, revise and approve validation protocols
  • Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
  • Review and approve manufacturing-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
  • Write inspection reports and prepare QA statements
  • Review and approve Certificates of Analysis and/or Certificates of Test
  • Perform internal and external audits of suppliers; assist in the resolution of non-conformances, deviations and investigations
  • Track open observations and Corrective and Preventative Actions (CAPA) to closure
  • Assist with the analysis of trends and metrics to ensure continuous quality improvements
  • Travel up to 20%
  • Other duties as assigned

Experience/Educational Qualifications

  • B.S. degree in a scientific discipline and at least three (3) years’ QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company
  • In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
  • Great attention to detail
  • Strong interpersonal skills
  • Strong prioritization, organizational and negotiating skills
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
  • Solid time management skills and ability to handle multiple tasks and deliver high-quality results within set timelines

Supervisory Responsibilities

  • This position does not have supervisory responsibilities

Please send CV and Cover Letter to hr@cellics.com to apply.

Our Mission

Cellics is committed to saving lives and improving patients’ health using innovative biomimetic nanomedicines. We strive to develop more effective and safer therapeutics and vaccines for diseases and unmet medical needs.

Our Info

11588 Sorrento Valley Rd.
Suite #20
San Diego, CA 92121

(858) 412-4156

info@cellics.com


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