Vacancy expired!
Seeking a Manufacturing/Ops Quality Engineer Level 2 for a 3 month contract plus possible extension with our global, award-winner biotech client in San Diego. On a day-to-day basis, you will be responsible for helping with ongoing activities within the department. You may also participate in an upcoming system migration.
Details: Start date: ASAP Duration: 3 months, potential to extend Location: Onsite at client's state-of-the-art facilitates in sunny San Diego, CA Hours:8 am - 4 pm Mon - Fri | (Flexible to start at 7 am if preferred) Compensation: $30-42/hr is the anticipated compensation plus benefits. The offered compensation to a successful candidate will be dependent on several factors that may include (but are not limited to) the type and length of experience within the industry, education, etc.This position is responsible for Manufacturing and Product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products (continuous improvement), and providing senior management with actionable process and product data. The position may also have responsibility for new product introduction (NPI) and/or quality oversight for more than one manufacturing area. You may participate in the sharing of best practices and lessons learned from NPI and Sustaining Quality. You may provide quality support to capacity expansion and new product development teams in the areas of process control, process verification and validation, design transfer, process validation, risk management, and specification development. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements. Ensure adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions. Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports. Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision-making. Review verification and validation reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner. Coordinate issue resolution using a risk-based approach. Ensure product manufacturing processes and validation programs meet requirements of FDA and ISO The position requires communication, interpersonal and project management skills to effectively coordinate activities and deliver results. A solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD and CMDR) is preferred.Soft skills: Strong communication, facilitation, planning, problem-solving and organizational skills. Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired. Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact. Flexible, with the ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.Requirements Bachelors in Science or Engineering Field. Background in chemistry, biochemistry or a related engineering discipline is preferred. Background in oligonucleotide synthesis and surface activation chemistry a plus. 2 - 3 years experience in the QA - Medical device field in a regulated environment. Direct experience working in in-vitro diagnostic development and/or manufacturing is preferred. Must be familiar with ERP (ideally SAP), PLM (electronic product life cycle management), MES (manufacturing execution systems), MS Word, Excel Possess effective data mining, trend analysis, and statistical analysis. Will trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis Has experience with enterprise Quality System tools (electronic CAPA, compliance management systems) and process improvement methodologies and tools Change management/product life cycle validation and non-conformant NCRteam center is a plusPlease Apply Today!- ID: #49012263
- State: California San diego 92101 San diego USA
- City: San diego
- Salary: USD TBD TBD
- Job type: Contract
- Showed: 2023-02-04
- Deadline: 2023-04-04
- Category: Et cetera