Qa Specialist, Toronto Jobs

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

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.
• Issue documents and logbooks as required.
• Develop processes and procedures for the quality department, under the guidance of the QA Manager.
• Support and participate with internal/external audits.
• Author investigations and procedures.
• Assign appropriate reviewers and approvers for procedures, policies and training.
• May perform other related additional duties as assigned.
• Review batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
• Participate in deviation investigations, CAPA, Change Controls, SOPs, etc. as applicable.

Requirements

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

Competencies

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

Benefits

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

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.

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

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.