Quality Assurance Associate

Company:

Elixir Associates are currently partnering with an exciting Clinical Stage Biotech based in Southern California company who are looking for a QA Associate as they build out their QA department.

About The Job:

The Quality Assurance Associate supports the routine monitoring and maintenance activities associated with the Quality Management System (QMS) in accordance with internal procedures, US FDA and as applicable, international current requirements across GCP, GMP, GLP and GPVP.

Key Responsibilities:

• Track training program compliance, Training Matrix for written procedures and refresher training, and assist with new staff on-boarding process
• Track, initiate and coordinate periodic review of controlled written procedures, Quality/ Service level Agreements, and supplier re-qualification cycles.
• Collaborate cross-functionally to develop and revise written procedures, forms and checklists.
• Assist QA team with development of training materials, scheduling of programs and completion of documentation
• Assist QA team with scheduling,logistics, travel arrangements, and communication of quality audits
• Conduct internal debarment checks and track/obtain from suppliers
• Enhance data integrity and documentation practices by converting paper-based forms/checklists to electronic systems
• Under direction, set-up systems for regulatory intelligence. Monitor and distribute outputs
• Gather documentation to facilitate authorization of initial shipment of IMP to clinical sites
• Track and trend metrics for internal quality systems such as deviations, quality issues, continuous improvement, supplier quality issues, etc.
• Assist QA team with development of presentation materials, communication tools, etc.
• Assist with compliance to document retention policy

Required Experienced:

• 3 years of relevant experience in a Quality Assurance support capacity within a regulated organization, bio/pharmaceutical experience preferred
• Attention to detail. Ability to ensure quality of work within time constraints.
• Excellent administrative and communication skills
• Ability to take direction, and work under pressure while maintaining composure and compliance to requirements
• Comfort with electronic software and applications.Advanced skills in electronic business applications including: WORD, PowerPoint, Excel, Adobe, Visio, SmartSheet, Sharepoint, BOX, etc.Familiarity and comfort with technical terminology, data collection/representation, graphic displays, basic mathematical/statisitical concepts
• Flexibility to adjust course when required
• College degree required, within scientific discipline preferred

Salary & Compensation:

Base Salary

Targeted Yearly Bonus

Healthcare Benefits

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