Quality Assurance

1 month ago

Toronto, Canada Ozmosis Research Inc. Full time

I. JOB SUMMARY


The Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.


II. QUALIFICATIONS


• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent

• Experience in some or all of Oncology, Clinical Trials, Good Clinical Practice, Quality Control/Assurance, Regulatory Affairs involving human subjects, preferred

• Experience in CTA including Preparation of Module 2, IND, ITA submissions preferred

• Good written and verbal communication skills, excellent organization, prioritization skills, excellent computer skills and the ability to learn quickly

• Ability to work under pressure and attention to detail

• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis Research Inc. standards

• Possess good critical thinking skills with the ability to multi-task

• Ability to work well as part of a team

• Relevant knowledge of Health Canada and FDA regulations relating to Clinical Trials


III. KEY ACCOUNTABILITIES & RESPONSIBILITIES


• Prepare and submit regulatory submissions (ex: CTA, CTA-A, CTA-N) to Health Canada and FDA according to regulatory requirements

• Liaise with regulatory authorities and internally to ensure that any requests for clarifications are responded to within the required timelines

• Assist with preparation for any regulatory meetings (ex: pre-CTA meetings)

• Perform quality control reviews and audits, communicate results to staff, SDQARA, other members of Senior Management and oversee all reports through to resolution

• Support the development and maintenance of tools, trackers, and documents relating to Regulatory Affairs, QC/QA including but not limited to the Master CAPA logs, SOP deviation logs, Internal Audit Tracking, etc.

• Support the maintenance of the eTMF index, plans, guidelines and other templates and coordinate eTMF issues between internal staff and vendor

• Responsible for the maintenance of SOP revisions, approvals and other documentation

• Responsible for the maintenance of Document Control documents and process

• Responsible for the maintenance of training documents, organizing training sessions for Ozmosis staff and assist with training on QA and Regulatory topics.

• Provide assistance to the SDQARA with metrics analysis, internal audits, preparation of external audits, vendor audits, site audits and writing of audit reports

• Contributing to applicable Ozmosis SOPs, documents, and guidelines

Other accountabilities and responsibilities may be required depending on business needs.


Ozmosis Research Inc. provides benefits, a generous pension plan and competitive salary that commensurate with experience and skills. Thank you to all applicants for your interest. Only selected applicants will be contacted.

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