- Cambrex High Point (Longmont, CO)
- …dose drug product. * Experienced with review and approval of equipment and instrument validation as well as associated computer software validation . * ... are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and...controls, and CAPA) in the QMS. * Creates departmental systems that foster a culture of quality and continuous… more
- Medtronic (Boulder, CO)
- …qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the ... following and other duties may be assigned. + Develop and execute validation strategy of various changes including scrap reduction, fixture improvements, supplier… more
- Medtronic (Lafayette, CO)
- …with customers (Spine Surgeons) to improve designs. + Understands verification and validation activities, ensuring products meet user needs, system requirements, ... and communicate results + Contributes and builds domain knowledge around spinal systems , their clinical use, and application via customer and field visits,… more
- Antech Diagnostics (Westminster, CO)
- …on emerging security threats, vulnerabilities and mitigation techniques. **Product Security Validation ** + Organize and support the product security review process + ... delivery and required level of quality in all aspects of the validation process. + Provide Standardized product security documentation. + Collaborate with other… more
- Novo Nordisk (Boulder, CO)
- …production. Routine interactions with analytical development for implementation and validation of analytical methods. Essential Functions + Requires full-time, ... with implementation and integration LIMS and other Novo software systems as they relate to Quality Control + Create...FTIR + Work closely with Analytical Development on method validation protocols and execution relevant to product methods +… more
- Medtronic (Lafayette, CO)
- …technical leadership in the definition, evaluation, and mitigation of risk of system designs in fast passing environment. This includes evaluation of system ... interfaces, use cases and conditions, investigating and resolving system and design issues, customized instruments to address customer feedback and requests. +… more
- OnKure, Inc. (Boulder, CO)
- …of GxP regulations, Quality Systems (including Document Control, Training, Change Control, computer system validation , 21 CFR Part 11) and relevant ... implementation of solutions Proficiency and experience with electronic Quality Management Systems including management and maintenance Experience with FDA and/or… more
- Cardinal Health (Denver, CO)
- …objectives. + Create, develop and maintain an effective Quality Management System that aligns with corporate procedures, client requirements and all applicable ... meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and… more