Quality Assurance Associate I

Cedent Consulting; Nova Scotia; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading consulting firm in Nova Scotia is seeking a Quality Assurance Associate II/III. This role involves supporting the Quality Assurance Department in compliance with regulatory requirements. Candidates should possess experience in pharmaceutical, GMP environments, and strong analytical skills. The position requires full-time work of 40+ hours per week and offers opportunities for training and operational improvements.

Qualifications

• Experience in quality assurance within a pharmaceutical or GMP environment.
• Knowledge of FDA and GMP regulations.
• Strong analytical skills and attention to detail.

Responsibilities

• Conduct quality assurance audits of production and facility records.
• Support GMP investigations and validation review.
• Participate in internal/external audits and prepare reports.
• Assist in the training of staff on quality assurance processes.

Skills

Project Management

Problem Solving/Analysis

Communication Proficiency

Technical Capacity

Collaboration Skills

Education

Bachelor's degree in a relevant field

Job description

Summary / Objective

This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Client compliance initiatives, including following all quality and division/company policy requirements. Helps to ensure that all Client products meet quality requirements by supporting all assigned quality aspects of product approval. The QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved.

Responsibilities

1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management.
2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
3. Supports resolution of technical and compliance issues/gap analysis.
4. Aides implementation of Quality Systems/System Improvements.
5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas.
7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.
8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA.
9. Work in coordination with regulatory affairs group in support of ANDA submissions.
10. Provides QA review/approval of all cGMP documents associated with manufacture of product.
11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
12. Authors or revises SOPs as necessary.
13. Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling, good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
15. Assist in development of special department projects and work in conjunction with quality management.
16. Other duties as assigned.

Competencies

• Project Management
• Technical Capacity
• Discretion
• Problem Solving/Analysis
• Decision Making
• Communication Proficiency
• Collaboration Skills
• Learning Agility
• Managing Changing Priorities

Position Type / Expected Hours of Work

This is a full-time position requiring 40 or more hours of work per week.