2 jobs found in Maple Grove

Quality Assurance Specialist Job Description The Quality Assurance Specialist is responsible for providing quality support to the pharmaceutical products portfolio, including products in development. This role acts as a quality liaison with cross-functional groups to facilitate continuous improvement, change management, risk management, and issue resolution. Responsibilities Perform executed batch record reviews and product disposition of finished products during product development and/or internal commercial operations. Create and revise Standard Operating Procedures (SOPs) as needed. Execute and approve investigations (e.g., complaints and deviations). Review and approve product-related documents including specifications, master batch records, change control documents, CAPA, investigations, deviations, regulatory submissions, and stability protocols. Assist Operations in situations requiring deviations or investigations. Assist with...

Summary: Perform tactical work and review a variety of documents, protocols, and reports. Project Details: Exhibit varying levels of experience and a solid progression of work and/or training Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies Review and approve manufacturing records, change controls, investigations and analytical data Review and approve test methods and method validations Review manufacturing validation protocol and reports Job Experience: Experience in small molecule manufacturing and contract manufacturing Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc. Excellent verbal and written communication...