- Company Name
- Xenon Pharmaceuticals Inc.
- Job Title
- Quality Control Associate 3
- Job Description
-
**Job Title**
Quality Control Associate
**Role Summary**
Full‑time QC Associate (18‑month term) responsible for managing outsourced quality control data, stability programs, and reference standard inventory for cGMP starting materials, drug substance (DS), and drug product (DP) across clinical and commercial pipelines. Works collaboratively with QC, CMC, Regulatory Affairs, and Quality Assurance teams to support product release, specification development, and regulatory submissions.
**Expectations**
- Minimum 2 days per week onsite (hybrid).
- Report to Director, Quality Control.
- Demonstrate strong analytical, data‑management, and regulatory knowledge.
- Communicate effectively across cross‑functional teams.
**Key Responsibilities**
1. Lead stability program activities for critical starting materials, reference standards, API, and DP, including scheduling, monitoring, and compliance.
2. Review, manage, and compile analytical results from internal and external partners; investigate deviations, OOS/OOT findings, and resolve issues.
3. Generate stability summary reports using stability management software; perform trending and statistical analysis for data‑driven decision making.
4. Coordinate stability data management (storage, protocols, shelf‑life extensions) across all programs.
5. Collaborate with QC, CMC Analytical, DS, DP, Regulatory Affairs, and QA to develop and update specifications meeting regulatory standards.
6. Serve as lead for the Specification Review Committee (SRC), collating changes and ensuring timely review.
7. Manage sample shipments to internal and external testing/manufacturing sites, ensuring traceability and compliance.
8. Oversee reference standard inventory: procurement, qualification, distribution, AND annual requalification updates.
9. Organize and archive internal/external QC data, protocols, and reports.
10. Support drafting and reviewing QC sections of regulatory submissions (INDs, IMPDs, CTAs, NDAs).
**Required Skills**
- Proficiency with stability management software and statistical tools (e.g., SAS, JMP).
- Strong analytical and problem‑solving abilities.
- Detail‑oriented, organized, and able to manage multiple priorities.
- Excellent written and verbal communication.
- Team‑player with collaborative mindset across disciplines.
- Familiarity with cGMP, QC, and regulatory submission processes.
**Required Education & Certifications**
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Life Sciences, or related field.
- Minimum 2‑year industry experience in pharmaceutical QC or a related cGMP environment.
- Certifications such as Certified Quality Auditor (CQA) or similar are a plus.