Raw Materials Associate I, Quality Control
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 aspects of QC for the organization and as 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:
- Deliver quality control related services as contracted, to various cell and viral product centered clients.
- Prepare documents for the release process of incoming materials for manufacturing.
- Perform inspection, sampling and testing of incoming materials, ensuring strict adherence to regulations and Organization SOPs.
- Perform the cleaning activities of the raw materials sampling room.
- Assist Raw Materials supervisor in the materials sample management program, including sample identification, storage, and retention.
- Adhere to the QC documentation (QMS) program, including SOPs, logbooks and associated forms.
- Work with QA, Production, SC and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.
- Assist in the OOS investigation as it relates to incoming materials, ensuring strict adherence to regulations.
- Provide support to Raw Materials Supervisor to complete the client project requirements.
- Ensures the Raw Material Sampling Room is always in a ready to use status for sampling.
- Support in coordinating the third-party testing by OmniaBio approved laboratories.
- Participate in Client audits and Health Authorities (HC, FDA, EU) audits as required.
- Assists in writing material specifications, SOP’s and maintaining logbooks/records.
- Provides support to generate department-related documents/presentations as directed.
- Assist in preparation of 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:
- 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.
- Open to flexible working hours, including evenings and weekends as needed.
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.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.