Quality Control, Raw Materials Associate Ii

2 months ago

Hamilton, Canada OmniaBio Full time

**Position Summary**:
As the Raw Materials Associate II, Quality Control at OmniaBio, you are an experienced person 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 II 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 technical assistance and will be an active contributor to client/regulatory audits, communicating to customers and management. You will ensure the high-quality delivery of contract services.

**Responsibilities**:

- Deliver quality control related services as contracted, to various cell and viral product centered clients.
- Assist Raw Materials Lead to generate and oversee the materials specification program.
- Prepare documents and assist in the release process of incoming materials for manufacturing.
- Perform sampling, testing of incoming materials, ensuring strict adherence to regulations and Organization SOPs.
- Perform and/or oversee the cleaning activities of the raw materials sampling room.
- Assist Raw Materials Lead in the materials sample management program, including sample identification, storage, and retention.
- Review completed records, logbooks to ensure compliance to GMP.
- Work with QA, Production, SC and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.
- Perform the OOS investigation as it relates to incoming materials, ensuring strict adherence to regulations.
- Provide support to Raw Materials Lead to complete the client project requirements.
- Support the QC documentation (QMS) program, including writing SOPs, logbooks, and associated forms.
- Support the training programs to the new QC hires and completing the documentation.
- Ensures the Raw Material Sampling Room is always in a ready to use status for sampling.
- Support in managing the third-party testing by OmniaBio approved laboratories.
- Participate in internal audits and/or supplier audits as required.
- Participate in Client audits and Health Authorities (HC, FDA, EU) audits as required.
- Prepare deviations, corrective and preventative actions (CAPA), Change Controls etc.
- Ensure GMP is embedded in all manufacturing related tasks.
- Engage and support the OmniaBio Operating Model (OBOM) continuous improvement philosophy.
- Represent OmniaBio and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
- Continuously grow and adapt 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**:

- Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, biochemistry, chemistry etc).
- 3-5 years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
- Experience working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities.
- Strong understanding of cell manufacture processes and technologies.
- Experience in QMS (Change controls, Deviations, CAPAs)
- Excellent understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles.
- Flexible to work in the fast-paced working environment.

**Desired Characteristics**:

- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.
- Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and work in a team environment.
- Experience establishing customer-facing organizations and service models.
- Demonstrated initiative and the ability to deliver high quality outcomes.

Revision Number: OBQCRMAII-20240910

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