Quality Compliance Specialist/Quality Supervisor/Quality Engineer(Pharma Domain)

Amiseq - Salt Lake City, UT

Full-time

Salt Lake City, UT

Professional, Scientific, and Technical Services

About the position

The Quality Compliance Specialist/Quality Supervisor/Quality Engineer role is focused on ensuring compliance and quality assurance within the pharmaceutical industry. This position involves managing quality projects, supporting audits, and authoring GMP documents, all aimed at maintaining high standards of quality and compliance in pharmaceutical operations.

Responsibilities

• Manage and track tasks for assigned Quality projects to assure on-time completion for CAPAs and effectivity verification.
• Support internal audits and walk-throughs conducted by the Quality Compliance department and related follow-up actions/activities.
• Author and review standard operating procedures, forms, checklists, protocols, risk assessments, and other types of GMP documents.
• Collaborate with appropriate departments to resolve both technical and compliance issues related to Quality management system elements.
• Support execution of protocols, gather data and inputs, and write related reports.

Requirements

• Bachelor's Degree in a scientific discipline (biology, chemistry, or closely related field) or equivalent education/experience.
• Minimum of 7 years relevant progressive experience in the pharmaceutical industry.
• Minimum of 3 years of experience in Quality Assurance, Quality Engineering, or Compliance role within the pharmaceutical industry.
• Experience with GMP and CAPA.

Nice-to-haves

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS, and ERP systems.
• Self-directed with the ability to organize and prioritize work.
• Excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers and management.