What are the responsibilities and job description for the Quality & Compliance Specialist position at VitaCyte?
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
- Maintain the QMS to ensure compliance with ISO 9001 under the direction of the Dir of Quality Assurance
- Manage personnel training, inspection readiness, equipment maintenance, and supplier qualification
- Manage corrective action investigations
- Duties & responsibilities to support Director of Quality Assurance
- Manage site training program which may include designing training plans, maintaining personnel training files, metrics and trends reporting
- Manage inspection readiness which may include self-inspections and customer audits
- Manage the supplier qualification program which may include updating supplier management and risk classification procedure, supplier audits, and performance monitoring
- Review and sign off on manufacturing records
- Help maintain equipment and facility maintenance and calibration records
- Support deviation, corrective action, and root cause investigations
- Support change management processes and records
- Qualifications
- Education/Experience
- Associates’ or Bachelor’s Degree in Chemistry, Biochemistry, Biology, or Biotechnology with 1-3 years work experience.
- Experience in managing a QMS or maintaining ISO certification is preferred.
- Experience with eQMS and/or CMMS software preferred.
- Skills/Abilities
- Comfortable working in a laboratory environment including lab safety, general chemical knowledge, and recording results document-controlled quality management system
- Strong documentation skills
- Strong interpersonal and communication skills
- Strong problem-solving skills while working in a team environment
- Average physical strength
- 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.