Pharmaceutical Quality Assurance Specialist
2 weeks ago
Fusion Pharmaceuticals US Inc. is seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team.
We are committed to delivering innovative and effective treatments for patients with cancer. As a member of our quality assurance team, you will play a critical role in ensuring the quality and safety of our products.
About the Role:
- Perform quality control (release & retrospective) testing of finished drug products and drug materials according to testing methods (TMs), including analytical chemistry, and microbiological tests and other tests according to the USP, EP, BP.
- Support method development, transfer, and validation activities. Perform validation/transfer activities independently with guidance as per approved protocols.
- Write new test methods, SOPs, controlled forms, data entry templates, etc. Prepare validation protocols with input from SMEs. Author validation reports according to regulatory guidelines (ICH, USP, EP, etc.) with inputs from SMEs.
- Conduct technical (peer) review of laboratory records; Write technical documents (specifications, test reports, data summaries, investigations, deviation, CAPAs). Prepare CAPA implementation plans and participate in closing laboratory investigations.
- Conduct investigations for testing failure and non-conformances and implement corrective actions. Prepare CAPA implementation plans and participate in closing laboratory investigations.
Requirements:
- Bachelor's degree or equivalent experience.
- 2+ years of related experience in in a pharmaceutical Gx P environment, performing analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins.
- Proficiency with equipment data processing software such as Empower (HPLC, GC), ICP-MS Mass Hunter (ICP-MS).
- Proficiency with spreadsheets (e.g., Excel, Google Sheets), word processing software (e.g., Word) and ability to write technical documents and reports.
- Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
About Us:
Fusion Pharmaceuticals US Inc. is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. We are committed to making a difference in the lives of patients with cancer by delivering innovative and effective treatments.
Salary:$90,000 - $110,000 per year, depending on experience.
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