Job Details

Location: Vancouver, BC, Canada .
Start: ASAP
1 YEAR CONTRACT
Onsite 2 days/week
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We are seeking a Senior Quality Control Associate, to join our team. The Sr QC Associate will work flexibly across several small molecule drug development programs with an emphasis on managing outsourced analytical data and stability programs for the cGMP API and drug product (DP) manufacturing campaigns.
This position reports to the Director, Quality Control and will be in the Vancouver, BC, Canada location.

RESPONSIBILITIES:

• Support the management of stability programs for starting materials, reference standards, drug substances, and drug products.
• Maintain and update the QC stability tracker to monitor upcoming stability pulls, ensure timely execution by testing partners, and track data receipt for each timepoint.
• Compile stability summary reports, assist with data trending, and support shelf-life extension assessments.
• Track qualification and requalification timelines for reference standards and ensure data and documentation are properly organized and archived.
• Support procurement, qualification, and distribution of reference standards to manufacturing and testing sites.
• Organize and maintain QC data, protocols, and reports on internal drives.
• Track and ensure method validation protocols, reports, and final methods are saved and accessible.
• Assist in drafting, formatting, and routing SOPs, stability protocols, and other QC documents through document control systems.
• Collaborate with CMC Analytical, Regulatory Affairs, and Quality Assurance to ensure specifications and deliverables meet phase appropriate regulatory requirements.
• Coordinate and support sample shipments between internal and external testing sites, resolving logistics or customs issues as needed.
• Contribute to process improvement initiatives, including SOP updates, basic process mapping, and organization of stability data.
• Assist in drafting and documenting OOS and OOT investigations.
• Assist in the preparation and compilation of Certificates of Analysis (CoA) and Certificates of Testing (CoT), ensuring data accuracy and compliance with internal formats.
• Act in accordance with Company policies, including the Code of Business Conduct and Ethics.
• Perform other duties as assigned.

QUALIFICATIONS:

• Bachelor of Science or equivalent in organic/physical organic/analytical chemistry.
• A minimum of 4 to 5 years’ experience in the pharmaceutical industry related to pharmaceutical quality control.
• Knowledge and understanding of cGMP and the US, Canadian, and EU regulatory environments Previous experience with managing stability data is preferred.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
• Excellent attention to detail and commitment to providing accurate, high-quality work.
• Good organizational skills and the ability to manage multiple competing priorities.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.