Quality Technician - Simply Biotech

Quality Technician- Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?

Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Quality Technician with a biotech company in Aliso Viejo, CA who possesses : -1+ years of experience in quality-Experience with final packaging preferred-Experience working in a highly regulated environment preferred Email resumes to mlowe@ FULL DESCRIPTION : The selected candidate will be responsible for : -Read, comprehend, and follow documents related to manufacturing, inspection and quality systems for audits, compliance, and implementation.

• Audit and approve production records. -Verify production process via auditing / observation and testing.-Inspect process output and product parameters against specifications.
• Ensure routine compliance with process steps and proper documentation of records.-Maintain raw material lot information, monitor expiration date, and quarantine inventory when materials are expired.
• Performs incoming inspection on raw materials and incoming sub-assemblies / finished goods.-Collect data for process, quality system, manufacturing quality and performance metrics and generate reports for management review.
• Identify non-conformances, deviations, non-compliance, lack of calibration etc. and propose corrective actions to management.
• Facilitate Manufacturing Review Board and supports non-conformance decision process.-Govern and transact materials physically and through electronic system.
• Monitors laboratory and engineering equipment to ensure compliance with preventive maintenance and calibration programs.
• Performs laboratory notebook audits, inventory audits, and maintains QA retains.-Take initiatives for the process improvements changes as related to manufactured components and finished products for LAL.
• Responsible for assisting the Quality Assurance team with any ad hoc reports and assignments as required.-Perform incoming inspection and lot control activities of materials and parts.
• Assist Quality, Manufacturing and R&D groups in running validation, verification, and developmental studies, and defining processes.
• Development of inspection techniques and transfer to production and everyday use.-Monitor gowning and cleanroom logbook check per SOP to ensure all section of the cleaning log has been filled accurately and completely.
• Provide Good Manufacturing Practices (GMP) and Quality Standard Operating Procedures (SOP) training to relevant department.
• Create and review First Article Inspection Reports when necessary. The selected candidate will also possess : -Prior experience of working in cleanroom environment and / or medical device manufacturing is highly preferred.
• Professional, responsible, energetic, and accountable.-Excellent communication skills.-Intellectually curious and eager to learn.
• Individual must be Quality oriented and possess a natural ability to pay attention to details.-This job has no supervisory responsibilities.
• This position may be responsible for leading cross training efforts to other inspectors, technicians. -Associate degree () or equivalent from a two-year college or technical school;

six months to one-year related experience and / or training; or equivalent combination of education and experience.-Experience within a medical device company or regulated industry preferred.

• Microsoft Word; Microsoft Excel-Training to be completed per the training plan for this position as maintained in the document control system.
• Microsoft Word; Microsoft Excel; Microsoft Access; QuickBooks.Salary Range : $25-$26 / hr For immediate and confidential consideration, please email your resume to mlowe@
30+ days ago