Quality Assurance Manager

Quality Assurance Manager

Pelican Therapeutics

Pelican Therapeutics, a subsidiary of Heat Biologics, Inc. (HTBX), is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company with an energetic and accomplished team.

Position Information

Pelican Therapeutics is starting a laboratory in San Antonio, TX that will function as a GxP laboratory.  We are seeking an experienced individual for a Quality Assurance Manager position.  This position will be based in San Antonio, TX and will report to the Associate Director of Quality Assurance located in Durham, NC.  The Quality Assurance Manager will be responsible for helping to develop and implement the quality systems and standard operating procedures, provide analytical documentation review and approval, and maintain the document control system and training for the laboratory personnel.

The ideal candidate must be highly organized, detail oriented, can multi-task, is able to interpret and follow written procedures and verbal instructions, has knowledge of general laboratory practices and safety, can work independently and make sound decisions, and is proficient in computers and database software.

Relocation assistance will not be provided.

Responsibilities

  • Work with the Associate Director of Quality Assurance to develop quality systems for GxP Laboratory
  • Develop and author quality system SOPs.
  • Review and approve SOPs for GxP lab.
  • Review and approve GxP data, forms, and notebooks.
  • Work with various department leaders to develop and approve specifications and final Certificate of Analysis for sample testing
  • Organize and maintain document control system
  • Issue controlled forms, documents, and labels to the laboratory personal as needed
  • Maintain all equipment documentation
  • Maintain all employee training documentation
  • Train new employees on GxP documentation and procedures

 

Requirements

  • Bachelor’s Degree in a life science, biology, chemistry, biotechnology, or closely related field.
  • Knowledge of and experience in working in a GxP environment
  • Strong written and verbal communication and interpersonal communication skills to effectively interact with peers and associates within and outside the company
  • Proficient in MS Office Suite, including Word, Excel, and Power Point
  • Can Demonstrate effective time management skills
  • Ability to effectively multi-task to advance various ongoing projects.

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job activities, special assignments and less significant responsibilities may be required as needed.

We offer a competitive compensation and benefits package as well as an environment where the candidates’ contribution can lead to significant professional gain.

Job Type: Full-time

Education:

  • Bachelor’s Degree in a life Science

Location:

  • San Antonio, TX

Required work authorization:

  • United States

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc