Specialist Quality Assurance # JN -072021-67501

 Description

• Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Key Responsibilities

• Manage and own NC records for External Quality
• Manage and own CAPA records for External Quality
• Manage and drive Quality records to closure independently
• Escalate risks or roadblocks to management
• Drive continuous improvements and Client first mindset
• Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)

Authority

• Own Quality record content
• Works under minimal direction
• Identify opportunities and issues, then determine when escalation is necessary
• Proposes revisions to SOPs in area of responsibility

Basic Qualifications:

• Doctorate degree OR
• Master’s degree & 4 years of directly related experience OR
• Bachelor’s degree & 6 years of directly related experience

Preferred Qualifications:

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)