University of Rochester Quality Assistant, cGMP Facility in Rochester, New York

Opening

Time as Reported Grade 079 Microbiology & Immunology M&D;

Schedule

VARIES; WKENDS

Responsibilities

Position Summary:

The Quality Assurance (QA) Assistant will provide support to the QA Director to uphold quality and compliance for the Quality Management System of the Upstate Stem Cell cGMP Facility (USCGF). This includes ensuring adherence to applicable regulations, standards, and internal policies and procedures.

Responsibilities:

Under the guidance of the Research Quality and Compliance Director, with latitude for some independent technical judgment, specific responsibilities will include, but will not be limited to:

  • Assist in the development of QA standard operating procedures (SOPs) and the ongoing review and improvement of facility SOPs. Conduct training of other staff members in the Facility
  • Plan and conduct internal audits of quality system elements, inclusive of report preparation, audit response tracking, and monitoring/documenting action taken to correct deficiencies. With latitude for modifying methods and techniques, records, computes and analyzes quality system data; prepares reports; and makes recommendations.
  • Release raw materials for use in production and Quality Control processes. Obtain lot-specific Certificates of Analysis, reviewing results and labeling containers.
  • Qualify suppliers to ensure high quality raw materials are utilized in production processes. Assess suppliers’ quality systems via a questionnaire
  • Assist in the development and implementation of facility-related qualification programs (e.g. a gowning qualification and aseptic processing program)
  • Track and trend Quality System data to ensure facility control and timely implementation of preventive actions (e.g., environmental monitoring particle and viable counts, deviations, CAPA, etc.) and generate and disseminate monthly reports regarding equipment calibration, periodic document review, training compliance, etc.
  • Review Quality System records to ensure compliant results with applicable regulations and internal procedures (e.g., environmental monitoring data, room logs, equipment logs, etc.)
  • Ensure quality system records are adequately backed up in OnBase or other venue
  • Take part in QA audits that are conducted on a periodic basis and provide QA management with regular updates

Qualifications:

  • Minimum of an Associate’s degree in appropriate discipline plus 4-5 years specialized experience in related field, or equivalent combination of education and experience required.
  • Bachelor’s degree and working knowledge of the Food and Drug Administration (FDA) GMP (Good Manufacturing Practices) is preferred.
  • Experience conducting audits is a plus.
  • Ability to manage multiple projects and priorities.
  • Ability to work with spreadsheets and large datasets.
  • Good oral and written communication skills.
  • Comfortable working in an FDA-regulated environment.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Quality Assistant, cGMP Facility

Location: School of Medicine & Dentistry

Job ID: 214066

Regular/Temporary: Regular

Full/Part Time: TAR