Quality Assurance Associate, Toronto

3 weeks 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 Associate will be responsible for:

- Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.
- Batch record review and final batch release.
- Supplier audits and qualification.
- Managing quality events and the associated investigations at the site.

Objectives and Accountabilities
- Reviewing batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
- Involved in vendor qualification.
- Support and participate with internal/external audits.
- Drafting, evaluating, and reviewing Annual Product Quality Reports
- Review and evaluate compendia monograph updates and regulatory guidance updates.
- 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.
- 2-5 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.
- 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.

**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

Why joining POINT today will be the right career move for you:
There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:

- You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
- You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
- You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
- Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

**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)

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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