Quality Assurance Associate

Quality Assurance Associate VitaCyte LLC Indianapolis, IN Job Details Permanent | Full-time 12 hours ago Benefits 401(k) 401(k) matching Qualifications Computer literacy Full Job Description 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.