Quality Technician - Simply Biotech - TalentZok
Aliso Viejo, CA
About the Job
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@simplybiotech.com or call 858.225.4141
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 (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
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
Source : TalentZok
