Specialist Quality Assurance # JN -072021-67501
Thousand Oaks, California
Posted on: July 23, 2021
Industry: QA Testers
Job Number: 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)