# Quality Assurance Operations Analyst II

**Company**: GSK
**Location**: Quebec
**Work arrangement**: onsite
**Experience**: senior
**Salary**: 37.3439$/hour
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Canada---Quebec---Quebec/Analyste-AQ-Opration-II_448664?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/quality-assurance-operations-analyst-ii-5fe26340-b93/

## Description

As a Quality Assurance Operations Analyst II, you ensure that manufacturing and product release activities are carried out in accordance with licenses, applicable regulations, internal requirements, and customer expectations.

With your in-depth knowledge of quality systems and manufacturing and release processes, you act as a subject matter expert in your area of expertise. You support and influence partners to promote a strong quality culture and ensure operational compliance.

Responsibilities:

- Review and approve production records, master data, validation documents, and other required GMP documents based on complexity, criticality, and applicable requirements.

- Monitor quality deliverables associated with operational activities and product release according to established priorities and deadlines.

- Propose, verify, and authorize quality statuses in applicable systems, ensuring data consistency and decision traceability.

- Review and approve investigations, corrective and preventive actions (CAPA), and related tasks to ensure robustness and compliance.

- Assess the quality impact of deviations or situations that may affect compliance and contribute to defining appropriate actions.

- Provide quality assurance support to partners regarding GMP, quality systems, documentation, and operational issues.

- Maintain regular presence on the floor, including during tours and aseptic activities, to observe practices, support compliance, and manage unplanned events.

- Develop, execute, and document quality assurance activities, management follow-up, and quality follow-ups.

- Write, revise, or update sector GMP documents, including SOPs, LRP, release documents, AQL reports, PQR, and other applicable quality documents.

- Exercise critical judgment to prioritize deliverables, escalate issues based on criticality, represent the sector during inspections, audits, or quality interactions, and act as a subject matter expert or trainer as needed.

Qualifications:

- Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biochemistry, microbiology).

- 3 years of relevant experience in pharmaceutical quality assurance.

- Intermediate computer skills (Office Suite).

- Intermediate English language skills (written).

- Knowledge of GMP.

Benefits:

- On-site cafeteria

- Free gym membership for employees

- Accessible by public transportation

- Free parking

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## Skills

### Required
- Data Integrity
- Detail-Oriented
- Digital Fluency
- GxP Regulations
- Lean Management
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing

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