QA Specialist, Toronto

7 months ago

Toronto, Canada POINT Biopharma Full time

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT's active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN CANADA.

Location of Work

This position will be located onsite downtown at UHN near University Avenue and College Street.

Overview

Reporting into the Manager of Quality Assurance the Quality Assurance Specialist will be responsible for:

- Creation of standard operating procedures and other quality documentation.
- Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.
- Batch record review and final batch release.
- Providing guidance and support to plant personnel to ensure training and documentation practices are executed in accordance with cGMP, ICH Guidelines, Heath Canada and FDA Code of Federal Regulations for aseptic drug products.
- Managing quality events and the associated investigations at the site.

Objectives and Accountabilities
- Participate in the successful implementation of a quality system which supports the site's development, clinical and commercial manufacturing goals. This will include document management, investigations, audits and the corrective action/preventive action program.
- Develop processes and procedures for the quality department, under the guidance of the QA Manager.
- Author investigations and procedures.
- Assign appropriate reviewers and approvers for procedures, policies and training.
- Review batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
- Support and participate with internal/external audits.
- Participate in deviation investigations, CAPA, Change Controls, SOPs, etc. as applicable.
- Issue documents and logbooks as required.
- May perform other related additional duties as assigned.

**Requirements**:

- B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred.
- 4-6 years of experience in a GMP or equivalent regulated environment
- Experience in vendor qualification and audit.
- Training and experience in documentation control, change control, CAPAs and review of quality records.
- Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products preferred.
- Ability to work independently and possess excellent organizational skills.
- Experience with electronic data systems is a plus.

**Competencies**
- Excellent oral and written communication skills
- Demonstrated ability to function well in a collaborative team environment
- Ability to plan, develop and execute multiple projects under tight timelines
- Operate and execute with an extreme sense of urgency
- Excellent organizational and interpersonal skills
- Demonstrated proficiency in technical writing
- Ability to manage multiple projects, set priorities, and work in a fast-paced environment

**Benefits**
- Eligible for annual incentive bonus plan and stock options
- Healthcare plan (medical, dental, vision) - effective day 1
- Disability
- Life insurance
- RRSP matching plan
- Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
- $500 fitness reimbursement
- $50 cell phone reimbursement per pay check ($1,300 per year)

This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.

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