Manager/Senior Manager, Quality Assurance

· Remote, California
Employment Type Full-Time
Minimum Experience Manager/Supervisor

Job Summary: 


Viracta is currently seeking a motivated, energetic, and experienced individual for the position of Manager/Sr. Manager of Quality Assurance to join our growing team of experienced professionals. The position is responsible for managing day-to-day QA operation activities in compliance with GxP regulations and ICH Q10 Guidelines.  Position may be remote for the right candidate.

 

Key Responsibilities:

  • Write and review controlled documents including SOPs and Policies per the objectives of the company quality system and quality planning.
  • Support GxP (GMP, GCP and/or GLP) audit of Viracta’s vendors.
  • Ensure that current procedures and practices confirm to quality standards.
  • Assure that deviations and CAPAs are addressed in a timely manner and consistent with Good Documentation Practice and applicable GxP regulations.
  • Conduct training on internal procedures for stakeholder groups.
  • Ensure that training files are current and maintained per the internal procedure.
  • Act as an administrator for Viracta’s electronic document management system.
  • Ensure escalation of significant compliance matters to the VP, Quality Assurance.
  • Work with cross functional teams ensuring compliance to regulatory guidance documents and internal procedures.



Qualifications:

  • BS degree in a biologic or pharmaceutical field is required.
  • 5-8 years of QA experience in Pharmaceutical/Biotech industry.
  • Hands-on experience with electronic, paper or hybrid document management system.
  • Experience writing and reviewing SOPs, protocols, reports etc.
  • Experience in conducting quality investigations using root cause analysis.
  • Prior experience with GxP audits.
  • Excellent interpersonal and customer service skills.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or related software.
  • Occasional business travel may be required.


Viracta is an Equal Opportunity Employer

 

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  • Location
    Remote, California
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor