Quality Assurance Associate

Quality Assurance Associate CGT Global Folsom, CA Job Details Full-time $24 - $26 an hour 2 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance Life insurance Referral program Qualifications Biology Document control within pharmaceutical industry Inventory management Pharmaceutical regulatory compliance Bachelor's degree Pharmaceutical company experience Quality inspection Quality audits Production batch record review GMP for research safety and compliance Pharmaceutical manufacturing facility experience Full Job Description About Us The mission at CGT Global is to accelerate the cure and prevention of significant medical conditions at life-changing speed. In 2010, the company was created to expedite research and clinical trials through the implementation of our own collection centers and state-of-the-art cell manufacturing laboratories. We support medical research, gene therapies and clinical trials by collecting human bone marrow and blood cells from our donors and sending to our clients. We provide expediency from order to delivery and guarantee every sample arrives with the highest purity, viability, and quality that researchers need to ensure confidence in their results. By shortening the time it takes to collect samples or isolate primary cells, we can help reduce months, and even years off a project. That means new cures and treatments can reach patient care faster, giving months and years back to the people afflicted with serious medical conditions. The Role The Quality Assurance Associate will play an integral role in helping the company maintain accuracy in data collection and quality in data management. This individual will assist in the management and implementation of the Quality Management System to ensure compliance. To be successful, the Quality Assurance Associate will do the following:

• Support the QA team with batch specific investigations and product disposition to allow on time batch release
• Ensure continuous compliance of Lab and Collection Center operation to GMP, local procedural requirements, and corporate policies
• Support and lead problem solving investigations for product and process deviations and customer complaints
• Active involvement in Laboratory Batch Record Review and Shipment approval.
• Continuous improvement, Lean / Six Sigma approach
• Provide coaching to other functions by using problem solving methods, root cause analysis and investigational tools
• Collect data, identify key KPIs for product quality reporting and present metrics to management
• Perform QA review of CAPA, Change Control, Document Control and Validation documentation
• Manage logistics of Change Control Board meeting
• Support NOE meetings and discussions
• Collaborate with other functional teams to ensure implementation of CGT Global Quality Management System
• Read, understand and follow all cGMP and cGLP documentation for Quality System Functions (SOPs, WIs, etc.,)
• Within 90 days of hire, must complete training in GXP, SOP/WI, Safety and QMS
• Contribute to the qualification/validation of facilities, utilities, laboratory, and manufacturing equipment
• Support the Quality team in day-to-day activities
• Assist in GMP audits as required
• Other duties as assigned Minimum Qualifications
• Bachelor's level degree in biological science or related discipline
• Experience in relevant final product release, batch record review, quality system within the pharmaceutical or medical industries
• Experience working with Quality Management Systems
• Experience with methods of inspection, inventory management, process control, and improvement techniques
• Working knowledge of GDP, cGMP, and cGLP regulations Preferred Qualifications
• Experience working in R D and GMP spaces.
• Knowledge of cell separation, flow cytometry, software and applications desirable.

Pay:

$24.00 - $26.00 per hour

Benefits:

401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Vision insurance

Work Location:

In person