About the role

Quality Assurance Specialist reviewing compliance documents and overseeing quality systems in biopharmaceutical manufacturing. Collaborating with multiple departments and leading improvement initiatives.

Responsibilities

Perform the following daily functions, but not limited to: review deviations, investigations and CAPA;
Review procedures, batch production records (BPR), logbooks, reports and any documentation generated by Manufacturing and other departments;
Review/approve quality- and operations-related activities and documents (logbooks, room/equipment status, training records, investigations, etc.) related to change requests, deviations, investigations and CAPA, as required;
Review/approve quality systems such as deviation management, quarantine, lot release, SAP, the SAP Quality module, documentation, and provide quality input for validation projects;
Coordinate the periodic review of procedures and other quality documents;
Initiate deviations, investigations, CAPA and change requests related to GMP documents/processes, as required;
Ensure the integrity and traceability of all generated and reported data;
Generate new procedures and revise existing procedures, as needed;
Gather data on deviations, investigations, CAPA and change requests for annual product reviews;
Provide support to other departments such as Production, Quality Control, Validation and Engineering;
Develop and report quality metrics for deviations and other systems, as assigned.

Bachelor of Science degree minimum (preferably in Microbiology, Chemistry, or Biology);
At least 2 to 3 years of Quality Assurance experience within the biopharmaceutical or pharmaceutical manufacturing industry;
Specialist-level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments);
Proficient computer skills with MS Office and Adobe Acrobat;
Strong organizational skills, including attention to detail and ability to meet deadlines;
Able to apply, follow and rigorously maintain rules, regulatory requirements, procedures and processes;
Able to work independently and as part of a team;
Capable of multitasking while collaborating to meet and exceed objectives;
Lead initiatives to improve company practices, processes and product quality;
Strong verbal and written communication skills and good interpersonal abilities;
Bilingual in French and English (fluent).