Quality Control Technician
Cygnus Technologies Inc. (part of Maravai Life Sciences) is focused on supplying highly specialized analytical products to the pharmaceutical and biotechnology industry for use in process development and quality control. As recognized experts in bioprocess contaminant testing for analysis such as host cell proteins, Cygnus offers a broad menu of well-validated, robust generic kits and immunoassay reagents. Cygnus also offers custom product-specific development of antibodies and assays for companies who want to outsource these highly specialized technologies to the experts.
Cygnus Technologies is seeking a Quality Control Technician responsible for working with the product development team (R&D) as the quality representative to ensure all aspects of design control for new and custom products are met prior to product launch or custom product delivery. Ensure compliance with applicable domestic and international standards and regulations.
- Lead the design control quality system development and implementation for custom products used in clinical research and for new products used for research use only.
- Work with custom product customers and product development team on all aspects of new product development and transfer/scale up activities; including, project scope, user needs, defining verification and validation requirements, product specifications, and other quality requirements. Provide guidance and support for test method development and process validation activities.
- Review and approve quality agreements and other customer contracts containing quality related information for custom product customers.
- Lead team in risk identification and mitigation activities during risk management process.
- Lead discrepancy investigations initiated during custom product development/manufacturing.
- Lead customer quality audits for custom products.
- Works with supplier quality on qualification of new suppliers, supplier discrepancies, and change notifications for custom products.
- Collect, evaluate, and report product development data.
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventative actions and effectiveness. Use of quality tools, such as FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Participate on internal audit team and support external audits.
- Helps train others in design control and other quality system processes.
- Work with R&D, manufacturing, quality, technical support, materials management, etc. to identify opportunities for improvement. Manage quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
- Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
- Quality professional with 3-5 years experience in a quality and/or specialized technical role in a life science industry.
- Requires knowledge of ISO 9001, ICH Q7, 21 CFR 820, or 21 CFR 210/211.
- Must have working knowledge of design control processes.
- Strong verbal and written communication skills.
- Strong interpersonal and customer interfacing skills.
- Strong problem solving skills.
- Self motivated and able to organize and prioritize mulitple tasks.
- Indentify quality issues/discrepancies and effectively resolve discrepancies within the organization.
Cygnus Technologies offers a competitive salary and benefits program.
Cygnus Technologies is an EEO Employer.
BS Degree in scientific discipline, advanced degree a plus.