Quality Assurance Associate

VitaCyte is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme-mediated cell isolation and other biotherapeutic applications. The company has established a Quality Management System (QMS) to comply with ISO-9001 and aligned with industry standards and regulations. 

• Job Purpose
  • To ensure that products, processes, facilities, documents, and systems comply with the Quality Management System and conform to established regulatory standards.
• Duties & Responsibilities
  • Drafts, revises, and maintains controlled procedure policies and procedures that are part of the QMS as directed by the Director of Quality Assurance.
  • Reviews QC results to ensure completeness and accuracy against established specifications.
  • Serve as a document controller by maintaining all hard copies of company quality related records in an organized fashion.
  • Along with the QA Director, facilitates internal audits.
  • Works to close identified gaps from audits, deviations, CAPA, and change controls.
  • Reviews and maintains training records of all individuals at the company.
  • Mentor non-QA staff, as needed, in authoring quality documents, including changes and deviations.
  • Work closely with manufacturing and QC teams on documentation.
  • Serve as verifier on batch release documentation.
  • Authors QA related deviations and change controls.
  • Responsible for following all safety requirements.
• Qualifications
  • Education/Experience
    • BA/BS in from an accredited institution in a relevant field (physical sciences, biological sciences). Direct relevant work experience will be considered.
    • Minimum of four years direct experience in a quality assurance role.
    • At least two years direct experience in a biological or other pharmaceutical setting is preferred.
    • Experience with eQMS and/or CMMS software preferred.
    • Auditing experience is preferred.
  • Skills/Abilities
    • Comfortable working in a laboratory environment.
    • Strong computer skills including comfort using web-based software tools.
    • Strong documentation, interpersonal, communication and problem-solving skills while working in a team environment.
    • Average physical strength and ability to stand for long periods.
• Benefits
  • Full time, permanent position including a comprehensive family medical benefit package and participation in an employer matched 401K plan. Salary is commensurate with experience.