We're looking for a Quality Assurance Specialist, working in the Biotechnology/Medical Devices industry in San Dimas, California, United States.
Investigates and writes investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
Conducts root cause analysis and utilizes critical thinking when identifying and analyzing information accuracy and reliability.
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analysis and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Conducts or serves as a lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.
The pay range we are offering is 32 to 35 per hour. This position may present an opportunity to go permanent.
Our client is a people driven staffing company. Growing fast - 33% annually!
How? Building trusting relationships with top candidates. Like you! You’ll get one-on-one time focused on your skills, needs, and discovering opportunities in which you’ll thrive. The goal is to place you in the right position for you and your goals.
Where? Top IT and telecommunications companies. You’ll make a difference and grow in Technology, Government Services, Professional Services, or Engineering.
Helping you achieve your goals! It’s the right way and the only way to succeed in staffing.
Experience Required for Your Success
BS/BA degree with educational background in Engineering, Biology, Chemistry or related science
2-3 years of relevant experience
QA experience preferred
Strong writing skills to present findings in a clear and concise manner
Detail-oriented and able to demonstrate a high standard of integrity
Desire to demonstrate excellence by setting high standards
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.