Quality Specialist

BioSpace; Thames Centre; On-site; CAD 55,000 - 75,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Specialist to ensure compliance with regulatory standards such as cGMP and ISO 17025. The position involves reviewing key analytical documentation, supporting internal audits, and contributing to quality management processes. Ideal candidates will have a degree in life sciences and experience in Quality Assurance.

Qualifications

• 2 years of experience in Quality Assurance, Sterile Compounding, or GMP production preferred.
• Knowledge of FDA regulations (cGMP) is preferred.
• Certification from ASQ is preferred.

Responsibilities

• Ensure compliance with company policies and Quality Management System.
• Write, review, and approve SOPs, test methods, and GMP records.
• Support and conduct internal audits to ensure compliance.

Skills

Organizational skills

Interpersonal skills

Communication skills

Attention to detail

Conflict resolution

Education

Bachelor of Science in life sciences or related field

Tools

Microsoft Office

Data management software

Job description

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The Quality Specialist is responsible for reviewing analytical documentation, including methods, validations, protocols, analytical data, reports (microbiology and chemistry logs and worksheets), investigations (OOS, NCR, CAR, DV, and customer complaints), and change control documentation. The role requires the ability to interpret and apply standards such as Current Good Manufacturing Practices (cGMP), ISO 17025, American Association for Laboratory Accreditation (A2LA), U.S. Pharmacopeial Convention (USP), and Good Laboratory Practices (GLP).

Responsibilities

• Ensure compliance with company policies, SOPs, and the Quality Management System.
• Ensure adherence to ISO 17025, cGMPs, cGLPs, and USP guidelines.
• Write, review, and approve SOPs, test methods, reports, logs, work instructions, deviations, CAPAs, change controls, and other GMP records.
• Review laboratory test reports, environmental monitoring, and QC data.
• Support and conduct internal audits and daily walk-throughs to ensure departmental compliance.
• Review root cause analyses and corrective actions for process issues.
• Assist in creating and maintaining quality documentation such as manuals and procedures.
• Manage the storage of quality documentation and quarantined items.
• Prepare training materials for all departments.

Qualifications

• Bachelor of Science in life sciences or related field.
• At least 2 years of experience in Quality Assurance, Sterile Compounding, or GMP production preferred.
• Experience with FDA-regulated operations (cGMP) preferred.
• Proficiency in Microsoft Office and other data management software.
• Strong organizational, interpersonal, and communication skills.
• Attention to detail and conflict resolution skills.
• Ability to work collaboratively in a team environment.
• Knowledge of 21 CFR Part 210 & 211 is a plus.

Certifications

• ASQ certification preferred.

Equal Opportunity Employer

This employer complies with federal employment laws. For more information, review the Department of Labor's "Know Your Rights" notice.

Additional Details

Seniority level: Entry level

Employment type: Full-time

Job function: Quality Assurance

Location: Middlesex, Ontario, Canada