Quality Specialist

BioSpace; Southwestern Ontario; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading biotechnology company in Ontario is seeking a Quality Specialist to ensure compliance with cGMP and ISO 17025 standards. Responsibilities include reviewing analytical documentation, writing SOPs, conducting audits, and managing quality records. The ideal candidate holds a Bachelor's degree in life sciences and has experience in Quality Assurance or GMP production. Strong organizational skills and attention to detail are essential for this role.

Qualifications

• Two years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred.
• Two years’ experience with FDA regulated operations (cGMP processes) preferred.
• Knowledge of 21 CFR Part 210 & 211 a plus.

Responsibilities

• Ensure compliance with policies and Quality Management System.
• Write, review, and approve SOPs and test methods.
• Support and conduct internal audits of quality documentation.

Skills

Attention to detail

Organizational skills

Interpersonal skills

Time management

Conflict resolution

Education

Bachelor of Science in life science or related field

Tools

Microsoft Office

Job description

Overview

The Quality Specialist is responsible for the review of 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. Possess the ability to interpret and apply Current Good Manufacturing Practices (cGMP), ISO 17025 standards, American Association for Laboratory Accreditation (A2LA) requirements, U.S. Pharmacopeial Convention (USP), and Good Laboratory Practices (GLP).

Essential Responsibilities

• Ensure compliance with Eagle policies and Standard Operating Procedures (SOPs) and Quality Management System.
• Ensure ISO 17025, cGMPs, cGLPs, USP guidelines are interpreted and followed throughout the Eagle.
• Write, review, and approve SOPs, test methods, laboratory reports, laboratory logs/worksheets, work instructions, forms, deviations, CAPA’s, change controls, and other relevant GMP records for compliance.
• Review laboratory test reports, environmental monitoring, and quality control data.
• Support and conduct internal audits of quality documentation and system and perform daily walk-through audits to ensure compliance of all departments.
• Review root cause analysis and implementation of corrective action for process related concerns.
• Assist in creating and maintaining company quality documentation, such as quality manuals, quality procedures, etc.
• Manage auditing and storage of quality documentation and quarantined items.
• Responsible for the preparation of training materials for all departments

Qualifications

• Minimum Bachelor of Science in life science or related field required.
• Two (2) years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred.
• Two (2) years’ experience with FDA regulated operations (cGMP processes) preferred.
• Strong Microsoft Office with ability to input data into other software programs.
• Excellent organizational, interpersonal, and time management skills.
• Excellent attention to detail with strong verbal and written communication skills.
• Ability to provide conflict resolution, i.e., quality issues operations.
• Ability to work in a collaborative team environment.
• Knowledge of 21 CFR Part 210 & 211 a plus.

Certifications

• ASQ preferred

Equal Opportunity Employer

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