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Stellar Biotechnologies, Port Hueneme, CA Full time Quality Specialist Stellar’s core business is the manufacture and supply of KLH protein under the brand name Stellar KLH™. Our products include Stellar KLH™ protein in various grades, formulations, and configurations for both clinical and research applications. Stellar KLH™ can be used for therapeutic vaccine conjugation, as a carrier molecule in immunotherapies, and as an immune stimulant in immunotoxicology applications.
The Quality Specialist is responsible for assisting the Head of Quality with the development, implementation, and maintenance of quality systems, programs, and/or projects to ensure achievement of planned objectives and compliance with applicable regulatory requirements. Primary Job Responsibilities
Create, revise, review, and approve quality-related documents
Track and trend quality-related data, such as out-of- specification results, deviations, CAPAs, equipment and document change controls, and complaints
Monitor, verify, and/or audit operations to ensure compliance with applicable procedures, protocols, and regulations
Inspect and release materials
Administer the QA archives
Administer document change control system
Partner with the appropriate stakeholders to correct deviations and improve processes
Monitor product quality issues and assist in problem resolution
At least 3 years quality assurance and/or regulatory experience in a pharmaceutical or biotechnology manufacturing environment
Thorough knowledge of US and international cGMPs and related quality regulations
An understanding of biotech manufacturing processes
Basic knowledge of laboratory analytics
Technical writing skills
Strong communication and problem-solving skills
Able to think logically and abstractly: recognizes discrepancies, connections and structures
Thorough hands-on knowledge of computer applications including Word, Excel, and Power Point
Johanson Technology, Inc. (Camarillo) Quality Engineer (Contract- 6mo+)
Johanson Technology, Inc. (JTI) is a manufacturer and distributor of various electronic components. It is located in Camarillo, CA. with affiliate locations in Southern California, and China. We’re currently seeking a dynamic, professional individual that is eager to make a difference! We are looking for a team oriented individual with outstanding organizational skills, a high degree of flexibility who will explore possibilities beyond the job boundaries. We are seeking a motivated Quality Engineer to provide factory quality support by monitoring, facilitating, measuring and assessing the effectiveness of products to ensure 100% product and/or service compliance with customer, regulatory and company requirements.
Review in-process and finished product against customer drawings. Lead AEC-Q200 product qualification projects. Prepare AS9102 first article inspection reports and data packages as required by customer orders.
Work with design, manufacturing engineering, and production teams to review customer orders during product realization to ensure compliance with all customer and company drawings/standards via PPAP, Gage R&R, Design of Experiments (DOEs), Statistical Process Controls (SPC), etc.
Perform internal quality systems/process audits and external supplier audits to verify compliance to ISO 9001/14001/AS9100/Mil790 standards. Assign 8D corrective actions to analyze root-cause and implement corrective actions if non conformances are detected.
Work with production supervisors and manufacturing/inspection personnel to insure proper training/understanding of production processes, procedures, and work instructions. Update documentation and provided additional training, as needed.
Conduct failure analysis on customer returned product to determine root cause and corrective actions. Complete 8D report and work directly with customer to insure problems are resolved and customer satisfaction is obtained.
Assist MRB team in reviewing non-conforming product. Perform failure analysis on discrepant material to determine root cause and implement corrective actions.
Conduct Process Audits, implement Operational Metrics and Continuous Improvement initiatives, including Statistical Process Controls where applicable.
Job Requirements: • Must be a U.S. Person. • Requires Bachelor’s Degree in related field or equivalent. • At least a minimum of five years of work experience in quality management, quality engineering or related engineering, manufacturing processes, or supply chain discipline. • Advanced ability in operating a computer and in the use of Microsoft Word, Microsoft PowerPoint, Microsoft Access, Microsoft Project, Statistical Process Control applications.
We offer a competitive salary. Benefits through Temp agency or JTI depending upon staffing situation.
Johanson Technology, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, gender identity, or pregnancy, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.