Quality Technician - Simply Biotech
-1+ years of experience in quality-Experience with final packaging preferred-Experience working in a highly regulated environment preferred Email resumes to mlowe@simplybiotech.com or call 858.225.4141
FULL DESCRIPTION:- The selected candidate will be responsible for:
-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 (A.A.) 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@simplybiotech.com or call 858.225.4141. More information can be found at www.simplybiotech.com