QA for QC Specialist (15-month contract)

We are looking for an enthusiastic QA for QC Specialist to join our Quality Assurance Operations team and help ensure the quality and compliance of the data behind our biologics clinical manufacturing. In this role, you'll review and disposition the data generated from the cGMP Quality Control (QC) labs, which support our state-of-the-art biologics drug substance clinical manufacturing facility. As the QA partner for QC, you'll oversee laboratory activities and help make sure our processes and procedures meet the highest standards of quality and compliance.

Responsibilities

Developing and supporting departmental processes, procedures, documents, and records for QA of QC-related operations; Reviewing manual and electronic data from testing of incoming materials and components, environmental monitoring and clean utilities, in-process bulk DS/DP, FDP, stability programs, retention/reference samples, reference standards, and cell banking activities; Approving protocols and reports for QC equipment and instrument qualification and validation, method transfers, and method verification/qualification/validation, along with ongoing monitoring reports such as EM and utility trending, APQRs, and QC method monitoring; Documenting and escalating QC data issues, including errors, inconsistencies, non-compliance, and suspected or confirmed OOT/OOS results, and dispositioning QC data generated during investigations and product complaint investigations; Participating in quality events such as deviations, CAPAs, and change controls to drive closeouts and root cause determination; Compiling and reviewing QC data for regulatory submissions (e.g., IND/CTA) and partnering activities, and supporting responses to official requests for additional information; Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility, while keeping a strong working knowledge of relevant compendia, regulatory standards, guidance, and QC instrumentation and operations

Requirements

BSc in a relevant scientific discipline with 5+ years of industry experience (or MSc with 3+ years); strong background in analytical sciences, quality control, or manufacturing of biologically derived drug products; thrive in a fast-paced environment, ensuring timely review of QC testing, procedures, batch documentation, logbooks, deviations, CAPAs, and change controls; high attention to detail with a focus on data integrity and compliance; strong interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; thorough understanding of cGMPs, Health Canada, FDA, EU, and ICH requirements

Benefits

Annual bonus dependent on individual and company performance; 6% non-match RRSP contribution; CAD $1,500 annual Active Lifestyle Allowance; annual vacation; professional development opportunities; comprehensive health benefits; scientific and technical mentorship; strong sense of community through work, clubs, and socials