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Quality Assurance Specialist

3 months ago

Old Toronto, Ontario, Canada Apollo Health and Beauty Care Full time

Apollo Health & Beauty Care is a leading provider of private label and control label health and beauty care products, renowned for its expertise in developing products that rival the most recognized national brands. As the largest private label personal care manufacturer in Canada, Apollo has a significant presence in the North American market and serves clients across Central and South Asia, Mexico, Europe, and Asia. Upholding our core values of Excellence and Commitment, we have positioned ourselves as a market leader attracting top talent in the industry. We are currently seeking a dedicated and proactive Quality Assurance Associate to contribute to our mission.

Position Overview

The Quality Assurance Associate plays a vital role in achieving project milestones and supports various quality management activities, including Annual Product Reviews, Management of Deviations, CAPAs, Change Management, and SOP Management, ensuring compliance in the manufacturing, packaging, and release of commercial products.

Key Responsibilities
  1. Prepare APR reports on schedule, compiling data from batch records, investigations, product modifications, and customer feedback.
  2. Work collaboratively with stakeholders to assess and manage Change Control Requests, ensuring adherence to GDP and change management protocols.
  3. Conduct internal audits to monitor compliance with the Quality Management System (QMS), covering production, facilities, validation, and laboratory operations.
  4. Identify opportunities for continuous improvement within the QMS in collaboration with Quality colleagues.
  5. Serve as a Subject Matter Expert (SME) in Quality Risk Management.
  6. Review deviation and investigation records, ensuring proper tracking, follow-up, and reporting/trending, while adhering to GDP and deviation procedures.
  7. Evaluate Corrective and Preventative Actions (CAPA) for effectiveness, including tracking and reporting.
  8. Facilitate timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations across departments.
  9. Assist the Quality Supervisor in reviewing batch records for product release.
  10. Create and maintain Quality Assurance and QMS standard operating procedures (SOPs).
  11. Oversee changes to controlled documents and systems, performing detailed impact analyses to ensure compliance with GMP and qualification requirements.
  12. Engage significantly with cross-functional teams, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
  13. Participate in cross-training initiatives with other QA Associates.
  14. Manage Logbook issuance, control, and review processes.
  15. Organize and maintain controlled documents.
Qualifications

Minimum of 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing environments. A Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field is required, along with a comprehensive understanding of cGMP/GDP international regulatory compliance and experience in a GMP setting. The ability to prioritize tasks effectively in a fast-paced environment and work on Quality projects that require data analysis is essential.

Interpersonal Skills

This role involves regular access to confidential information and frequent interactions both internally and externally, often concerning complex issues with significant consequences. Strong written and verbal communication skills are necessary for effective job performance.

Problem Solving

The position requires a high degree of autonomy, with regular analysis and decision-making that may not follow prescribed guidelines. The role involves frequently addressing complex technical challenges or personnel issues.

Mental and Physical Effort

High levels of concentration and attentiveness are required, along with moderate physical activity, including standing, walking, and lifting.

Environmental Considerations

The role is situated in an office environment within a manufacturing setting, with occasional exposure to various elements. The position may involve some travel.

Apollo Health & Beauty Care Ltd. is committed to providing accommodations for candidates with disabilities throughout the recruitment process.

This job description serves to outline the general nature and level of work performed by employees in this role. It is not intended to be an exhaustive list of all duties, responsibilities, and qualifications required. Duties may be modified at any time as requested by management.

We appreciate the interest of all applicants; however, only those meeting the minimum qualifications will be contacted for an interview.