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.
• Batch record review and final batch release.
• Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.

Objectives and Accountabilities

• Ability to work independently and possess excellent organizational skills.
• Review batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
• Develop processes and procedures for the quality department, under the guidance of the QA Manager.
• B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred.
• Issue documents and logbooks as required.
• Assign appropriate reviewers and approvers for procedures, policies and training.
• 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.
• Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products preferred.
• Support and participate with internal/external audits.
• Experience in vendor qualification and audit.
• 4-6 years of experience in a GMP or equivalent regulated environment
• Author investigations and procedures.
• Experience with electronic data systems is a plus.
• May perform other related additional duties as assigned.
• Participate in deviation investigations, CAPA, Change Controls, SOPs, etc. as applicable.
• Training and experience in documentation control, change control, CAPAs and review of quality records.

Competencies

• $50 cell phone reimbursement per pay check ($1,300 per year)
• Healthcare plan (medical, dental, vision) – effective day 1
• Ability to plan, develop and execute multiple projects under tight timelines
• Disability
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• Excellent organizational and interpersonal skills
• Excellent oral and written communication skills
• $500 fitness reimbursement
• Life insurance
• RRSP matching plan
• Operate and execute with an extreme sense of urgency
• Demonstrated ability to function well in a collaborative team environment
• Demonstrated proficiency in technical writing
• Ability to manage multiple projects, set priorities, and work in a fast-paced environment
• Eligible for annual incentive bonus plan and stock options

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.