Career Category

Job Description

Description

Provide tactical support activities to Site Leads across multiple Quality Systems and Processes through the Regional Work Cell Team.

Key Responsibilities

• Batch record archival
• Log LIMS batches
• LIMS sample plan creation/update
• Enter LIMS data
• Certificate of Analysis creation, as necessary
• Enter SAP master data
• Train on required Quality Systems to perform required tasks including record ownership of deviations, CAP, Change controls and Contract manufacturing oversight records.
• Escalate risks or roadblocks to management
• DMS regional representative
• Manage and drive process improvement initiatives

Authority

• Own basic quality record and document content
• Determines situations which require escalation to management           
• Works under general direction

Basic Qualifications:

• Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR
• Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience

Preferred Qualifications:

• 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• cGMP Experience
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• 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)