Senior Associate Quality Systems Jobs

Excellent project and data management skills and a keen attention to details

Experience in execution of internal audits and management of routine GxP inspections.

Manage ADCT Quality Event records, including Deviations, Change Controls, and CAPAs, to industry requirements

Support internal audit, inspection readiness, and inspection management activities

Other responsibilities as directed by manager

Ability to work independently and manage priorities in a remote setting while making sound quality/compliance-based decisions

Experience in change management or lean transformation an asset.

Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.

Implement / maintain electronic documentation and learning management systems in collaboration with NC-HC sites

Support site internal project(s) and temporary assignment(s) as assigned by Quality Management.

Participate in Quality Risk Management to support GMP operations

Effective and professional interpersonal skills with abilities to influence others across multiple functions.

Lead and direct team members to assist in maintaining the Quality management system.

5+ years of related experience in quality.

ISO 13485:2016 Internal Auditor Certification.

Experience with data process and statistical analysis.

Excellent verbal and written communication skills.

Excellent attention to detail and organization skills.

3+ years of People Management experience.

Demonstrated experience in executing quality management systems within heavily regulated environments.

10 years of Quality Systems experience.

Strong knowledge of domestic and international quality standards, including ISO 9001, ISO 13485 and/or other applicable regulations.

Experience in the healthcare, medical device, or pharmaceutical industry.

Lead investigations of incidents and accidents according to company reporting procedures, ensuring thorough analysis and the implementation of preventive measures.

Experience working in quality management systems based on quality standards such as ISO 9001:2015 and API Q1.

Knowledge and prior experience working within API Q1 and ISO9001 Standards.

Good computer skills, including an understanding of Microsoft Office Suite programs.

Team player with good verbal and written communication skills, able to follow and understand

Minimum 2 years of direct QC experience in a manufacturing or machining environment.

Lead or internal auditor training or certification is an asset.

Knowledgeable and experienced in: Lean, Six–Sigma, Process Approach Mapping, Project Management Practices and Data Analysis.

Required Knowledge, Skill And Abilities

Develop the Management Systems strategy, demonstrating solid progress against plan.

Regulate, Control, and improve the quality of all processes throughout the business. Lead the team to achieve quality management system targets.

Facilitate integration of other business aspects within the QMS, such as Safety, environment, efficiency – Total Quality Management mindset (TQM).

Minimum 10 years of relevant experience within a Manufacturing environment in a similar capacity

Establishing, supporting, maintaining, monitoring QMS framework processes and robust quality systems management program in compliance applicable global CMC/GMP requirements

5+ years of quality system management experience in a GxP regulated environment

You are enthusiastic about applying your expertise in quality systems management

Leading the management of Quality System execution, including Deviation, CAPA, Change Control, Complaints, as applicable

Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of AbCellera’s QMS, along with associated required improvements

Experience in GMP manufacturing, and testing requirements for biologics, including aseptic technique/operations, environmental monitoring programs, and media simulation studies