Job Description

The Ideal candidate must 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 own Change Control records internal to External Quality
• Manage and drive Quality records to closure independently
• Perform tactical batch disposition activities in support of lot release
• Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
• Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)
• Escalate risks or roadblocks to management
• Drive timely decision making using DAI principles
• Drive continuous improvements and first mindset
• Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)


Requirements

Basic Qualifications:
• Min Bachelor’s degree & 4 years of directly related experience
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Preferred Qualifications:
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry (med device will also be considered)
• 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

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