Job Description
About the Company
Founded in 2005, At RxSource, our purpose is to improve the lives of patients. We provide Clinical Trial Supply Chain Services and Pharmaceutical Procurement globally. With offices in Canada, the USA, and Ireland, we deliver tailored services to Pharmaceutical Sponsors, Biotechs, and CROs. Our team and culture are our most valuable assets, embodying our core values in everything we do. We see our clients as partners, and their success is our success
Position Summary
The QC Associate is a key member of the Quality Control function, responsible for ensuring that all materials and packaging operations comply with applicable regulatory requirements, internal procedures, and client expectations. This role focuses on executing in‑process inspections, performing incoming material checks, maintaining retention samples, and accurately documenting and reporting any non‑conformities. The ideal candidate is detail‑oriented, dependable, and comfortable working in a dynamic clinical trial environment.
Responsibilities
- Perform in‑process inspections during Clinical Trial secondary packaging and labeling operations to ensure compliance with batch records, specifications, and SOPs.
- Verify correct components, labels, quantities, and packaging configurations during operations.
- Conduct line clearance and area inspections prior to and after packaging runs.
- Inspect and release incoming goods, including clinical trial materials, packaging components, and labels, ensuring conformance with specifications, CoAs/CoCs, and GMP requirements.
- Document inspection results and escalate any discrepancies or non‑conformities.
- Maintain and manage retention samples, ensuring accurate labeling, storage, traceability, and periodic review.
- Ensure all QC records are complete, accurate, and compliant with GDP principles.
- Identify, document, and report non‑conformities, deviations, or defects to the Quality organization promptly.
- Support investigations by providing factual data, samples, or inspection summaries.
- Assist in implementing corrective actions where required.
- Adhere to all regulatory and internal SOP requirements during daily tasks.
- Participate in training, internal audits, and process improvements.
- Collaborate effectively with Operations, Logistics and Project Management.
- Monitor and document environmental conditions (e.g., temperature) in accordance with GMP and site requirements, ensuring any excursions are reported and managed appropriately.
Working Conditions:
- Work in controlled refrigerated (2–8°C) and frozen (–20°C) environments as required to perform in-process inspections for short or extended durations, depending on operational needs.
Qualifications
- College Degree in Life Sciences or 3+ years of experience working in pharmaceutical quality
- Computer literacy, proficiency with MS Office - including Outlook, Word, Excel, PowerPoint, Teams
- Experience working with Electronic Quality Management Systems (e.g. TrackWise, etc.) is an asset
- Excellent communications skills (verbal, written, listening, conveying messages)
- Detail-oriented
- Ability to work well under pressure
- Solid decision-making skills
- Highly adaptable, flexible professional who embraces teamwork, but also enjoys working independently
No matter your role at RxSource, successful team members are:
- Patient Champions, who put patients first and uphold strict ethical standards
- Achievers, who drive toward practical solutions
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed