View all jobs

Specialist Quality Assurance

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

Quality record ownership
Ability to work independently and meet short timelines
Ability to quickly shift priorities


Remote for now

***Local candidates only*** must be able to work onsite in Thousand Oaks when need be.

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 first mindset
• Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)

• 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)

"This posting is for Contingent Worker, not an FTE"

More Openings

.NET Programmer
IT Project Manager
Project Manager

Share This Job

Powered by