Job Description

Position Summary:

As the Raw Materials Associate I, Quality Control at OmniaBio, you are a motivated individual in the field of Quality Control for Good Manufacturing Practices (GMP) manufacturing. The Quality Control (QC) team is responsible for all aspect of QC for the organization and the Raw Materials Associate I, you will be required to work across the entire range of activities, including but not limited to materials sampling and testing, sample management, data review and raw material release activities. You will demonstrate flexibility within the quality and larger organization, following the work priorities as required. You will provide support to ensure the department activities are completed on time and as assigned. You will ensure the high-quality delivery of contract services.

Responsibilities:

Delivers quality control related services as contracted, to various cell and viral product centered clients. Prepares documents for the release process of incoming materials for manufacturing. Performs sampling, testing of incoming materials, ensuring strict adherence to regulations and Organization SOPs. Performs the cleaning activities of the raw materials sampling room. Assists Raw Materials Lead in the materials sample management program, including sample identification, storage, and retention. Adheres to the QC documentation (QMS) program, including SOPs, logbooks and associated forms. Works with QA, Production, SC and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices. Assists in the OOS investigation as it relates to incoming materials, ensuring strict adherence to regulations. Provides support to Raw Materials Lead to complete the client project requirements. Ensures the Raw Material Sampling Room is always in a ready to use status for sampling. Supports in coordinating the third-party testing by OmniaBio approved laboratories. Participates in Client audits and Health Authorities (HC, FDA, EU) audits as required. Assists in writing material specifications and maintaining logbooks/records. Provides support to generate department-related documents/presentations as directed. Assists in preparation of deviations, corrective and preventative actions (CAPA), Change Controls etc. Ensures GMP is embedded in all manufacturing related tasks. Engages and supports the OmniaBio Operating Model (OBOM) continuous improvement philosophy. Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits. Continuously grows and adapts in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy regenerative medicine fields. As required, any other related activities in the Quality Control Department.

Requirements:

Highschool + additional program of > 1 year in science (bioengineering, chemical engineering, bioprocess, biotechnology, biochemistry, chemistry etc.). Up to and including 1 year of practical and related experience and/or 6 months on-the-job training in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries. Able to work in a fast-paced environment.

Desired Characteristics:

Independent, detail-oriented, self-starter with the ability to multitask and succeed in a team environment. * Demonstrated initiative and the ability to deliver high quality outcomes.