Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support. This posting reflects an existing vacancy within our organization.

We are seeking a skilled and highly motivated Quality Assurance Associate with strong initiative and a commitment to GMP compliance. In this role, the successful candidate will help ensure that products manufactured for human use meet predetermined quality specifications, are safe for use, and are produced in accordance with applicable regulatory requirements, including Health Canada, FDA, and ICH guidelines. This posting reflects an existing vacancy within our organization.

Responsibilities:

GMP Compliance and Quality Oversight

- Provide GMP operational guidance and quality support to Dalton employees.
- Ensure documents in use are current, properly approved, and compliant with GMP requirements.
- Interpret project and client requirements and align them with applicable regulatory expectations.

Document Review, Approval, and Validation Support

- Write, review, and approve GMP documents, including master batch records, test specifications,



and SOPs, ensuring alignment with Dalton procedures, client expectations, and regulatory requirements.
- Review and approve executed GMP records, including batch records for sterile and non-sterile products, worksheets, and material release documentation.
- Review and approve media fill protocols and reports, as well as IQ/OQ/PQ protocols and reports.
- Support development of process validation strategies for new products, from submission batches through commercial manufacturing.

Investigations, CAPA, and Continuous Improvement

- Perform or support deviation investigations, including preparation or review of impact assessments and confirmation of root cause analysis.
- Develop, review, and approve SMART CAPAs; define appropriate effectiveness checks and ensure timely CAPA closure.
- Review environmental monitoring trend reports and support quality improvement activities as required.

Aseptic Operations, Audits, and Project Support

- Perform aseptic coaching and spot checks by observing operations during filling activities.
- Provide QA support during project calls, regulatory inspections, and client audits.
- Support the preparation of responses to external audit observations and inspection findings.

Administrative and Other Duties

- Perform administrative activities,



including attending meetings, completing timesheets, copying documents for customers, creating logbooks, filing GMP documents, and archiving GMP records.
- Perform other duties as assigned by QA management.
- Ensure documents in use are current, properly approved, and compliant with GMP requirements.
- Interpret project and client requirements and align them with applicable regulatory expectations.

Qualifications:

Education and Technical Knowledge

- Bachelor of Science degree in a relevant science discipline.
- University-level coursework in microbiology.
- Working knowledge of applicable GMP regulations, including Health Canada and FDA requirements.

Pharmaceutical and GMP Experience

- More than five years of experience in the pharmaceutical industry.
- Strong knowledge of aseptic and sterile manufacturing operations.
- Experience supporting process validation activities and batch release processes.

Communication and Computer Skills

- Strong verbal communication and interpersonal skills.
- Proficiency with Microsoft Office and general computer applications.

While we appreciate all the applications received, only those selected for an interview will be contacted.

Job Types: Full time, Permanent

Pay: $63,000.00-$68,000.00 per year

Benefits:

- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care

Application question(s):

- Can you work 100% on-site?

Education:

- Bachelor's Degree (preferred)

Experience:

- Pharmaceutical Quality Assurance and Compliance: 5 years (preferred)

Work Location: In person

📌 QA Associate (Operations) (North York)
🏢 Dalton Pharma Services
📍 North York