Job Details

Quality Assurance Compliance Specialist

Job Number:
J0118-0062 - Full Time
Saint-Laurent, Quebec
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Quality Assurance Compliance Specialist

A Global Leader in biopharmaceutical industry in Canada!

Title: Quality Assurance Compliance Specialist
Location: ST-Laurent, QC
Position status: Permanent, Full-time

TO APPLY: Please create a profile online and send your resume to Lynne at:

Company profile:
Our client, a healthcare company, provides safe and effective solutions to satisfy human health needs. The company is specialized in manufacturing biotherapeutic products.

• Be responsible for activities and quality systems
• Ensure that activities, operations and products fully comply with company standards
• Ensure Company’s activities comply to the applicable current regulations
• Performs risk assessments as needed, and assists in determining preventive actions to
prevent issues from occurring, for continual improvement initiatives, etc.
• Reviews and approves change requests related to quality, production, facility and utility systems
• Performs internal and external audits, as scheduled and assigned
• Conducts investigations, as required, ensures the event is well-described, identifies the potential quality impact
• Determines the root cause and corrective actions to minimize future events
• Reviews and/or approves working Instructions and forms
• Tracks and trends key quality performance indicators and conducts appropriate follow-ups as required
• Provides cross departmental support to quality control, production, validation, engineering, etc.
• Ensures the integrity and traceability of all data generated and reported
• Performs other duties as assigned by Quality Lead

• University Degree in Biology, Biochemistry, Chemistry, Microbiology or related discipline
• 7+ years of experience in QA within pharmaceutical manufacturing industries, preferably having experience in biologics manufacturing
• Excellent communication skills (verbal, written and presentation skills).
• Able to problem-solve, be proactive and multi-task under strict deadlines
• Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
• Must be an able to work independently and as part of a team
• Strong knowledge of and ability to interpret and apply the applicable regulations of Canada and US
• Highly organized, problem solving, analytical and focused;
• Detail-oriented, thorough and methodical with strong interpersonal, organizational and communication skills

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