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.