The Quality Specialist position is primarily focused on performing analytical and microbiological testing on raw materials, in-process samples, and finished goods to ensure product quality and compliance with specifications. The role involves accurate documentation of results, effective communication across departments, and active participation in maintaining quality standards. Detailed in documentation abilities proficient with computer systems Ability to work independently and prioritize workload as needed.

POSITION ACCOUNTABILITIES

The following are essential job functions.

Quality Control

• Perform routine testing on raw materials, in-process samples, and finished goods according to established methods
• Conduct and document microbiological assays (e.g., plate counts, contamination checks, etc.).
• Operate, calibrate, and maintain laboratory equipment.
• Interpret and record test results accurately; investigate out-of-spec results.
• Maintain the retain samples in accordance with company policy.
• Perform stability testing as needed to support product shelf-life and quality
• Support product release by ensuring all testing meets specifications.

Quality Assurance

• Support the implementation and maintenance of the ISO-based Quality Management System (QMS).
• Assist in internal and external audits (e.g., ISO, customer, regulatory).
• Help manage CAPAs and non-conformances, including conducting root cause analysis for performance issues.
• Communicate effectively with production, R&D, and management teams to resolve quality issues
• Assist in developing, updating, and maintaining SOPs and quality documentation.
• Contribute to continuous improvement by analyzing recurring issues and proposing preventive solutions.
• Participate in product validation, scale-up, and pilot production trials, providing technical feedback and quality input.
• Support risk assessments and contribute to risk analysis activities related to product quality, processes, and regulatory compliance.

Compliance

• Ensure compliance with relevant ISO 9001 standards and regulatory requirements.
• Develop, review, and maintain product labels and Safety Data Sheets (SDS) in compliance with GHS, WHMIS, REACH, and other applicable regulations.
• Support communication and coordination with regulatory bodies, customers, and suppliers regarding quality-related matters
• Stay updated on regulatory and industry best practices affecting quality and compliance.
• Support product registration and customer documentation needs (e.g.: Manufacturer's declaration, Flow Charts, etc.)

Secondary job accountabilities

• Other related duties as assigned.