Quality Assurance Process Release Specialist (Temporary)

Centre de production de produits biologiques (CPPB) inc. / Biologics Manufacturing Centre (BMC) Inc.; Montreal (administrative region); Hybrid; CAD 85,000 - 110,000; Full time

Benefits offered by this job

Flexible schedule

Remote work options

Competitive salary

Culture of transparency

Respectful work environment

State-of-the-art facility

Employee committees

Free on-site parking

Job summary

The Biologics Manufacturing Centre (BMC) Inc. is seeking a Specialist, Quality Assurance - Process to oversee product release activities for process intermediates, drug substances, and drug products, ensuring quality and compliance.

The role involves evaluating deviations, investigations, change controls, and CAPA recommendations. This is a temporary assignment of approximately 13 months to cover a leave of absence.

Qualifications

• Bachelor's degree in a relevant field is required.
• Minimum five years in a GMP-regulated pharma/biotech environment.
• At least one year in finished product release.
• Strong knowledge of GMP and GDP guidelines.
• Ability to read English technical documentation and communicate in French.

Responsibilities

• Release products (process intermediates, drug substances, drug products) per manufacturing activity and timelines.
• Review COAs, batch records and related docs for accuracy and compliance.
• Issue certificates and approve product COAs.
• Identify and assess deviations affecting product quality.
• Lead quality event investigations with internal stakeholders.
• Prepare investigation reports within established timelines.
• Lead risk prevention activities and GEMBA walks.
• Coordinate change controls from approval to closure.
• Review documentation for aseptic process simulations and validation reports.
• Serve as resource for GMP/GDP activities and for employees involved in product release.
• Occasionally release raw materials and production support items; approve COAs during peak periods.

Skills

GMP knowledge

Quality assurance

Documentation review

Investigations

Change control

French communication

English reading Comprehension

Education

Bachelor's degree in a relevant field

Job description

The Biologics Manufacturing Centre (BMC) Inc. is seeking a Specialist, Quality Assurance - Process to oversee product release activities for process intermediates, drug substances, and drug products, ensuring quality and compliance.

The role involves evaluating deviations, investigations, change controls, and CAPA recommendations. This is a temporary assignment of approximately 13 months to cover a leave of absence.