Job Description

working remote until COVID-19 restrictions are lifted 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 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 • 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 • Drive continuous improvements and client first mindset • Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, 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 & 2 years of directly related experience OR • Bachelor’s degree & 4 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications: • 4+ 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)

Qualifications

TOP 3 MUST HAVE SKILL SETS:

HARD SKILLS Strong quality knowledge (4+ years of experience) Strong knowledge of Quality systems and record ownership (4+ years experience) Experience of LIMS SOFT SKILL Ability to prioritize, quickly shift priorities, and meet due dates as assigned

Additional Information

DAY TO DAY RESPONSIBILITIES:

Own quality records such as deviations, change records, and CAPAs LIMS entries and approvals Document processing including revisions and uploads to electronic system