4300 Hacienda Drive Pleasanton, CA 94588
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
- Responsible for the support and coordination of operations in the laboratory areas.
- Maintain lab areas to ensure Quality System compliance, Safety compliance, proper equipment and laboratory consumables management.
- Uses independent judgment to execute work and utilize interpersonal skills to establish solid internal/cross functional relationships to accomplish goals.
- Supports operations of the tracking system within the System Support and Lab Service Department by coordinating vendor-performed work and update information in tracking systems, including both on-site and off-site services.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Maintain accurate inventory of supply and products.
- Support designated laboratory areas by engineers and scientists.
- Works with Lab Supervisor/Manager that oversees all lab activities.
- Trains and documents orientations for new lab users on laboratory organization, workflows, Quality System compliance, and Safety requirements.
- Manages lab documentation and lab training to ensure Quality, Safety and departmental compliance.
- Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact user’ s supervisor if necessary.
- Partners with department scientific staff, and cross-functionally with Subject Matter Experts in the Systems Support groups, Facilities, and other Department to ensure timely installation and operation of new/existing equipment.
- Ensures all lab consumable supplies available when needed.
- Addresses laboratory organization/waste/cleanliness issues with laboratory users, General Lab Support, and Facilities to ensure compliance.
- Response to freezer / fridge alarms per Rees protocol and development workflow.
- Coordinates with equipment owners across departments to obtain and send out measurement and test equipment/instrumentation for calibration by external service providers.
- Designates in and out of service status to prevent use of out of service or out of calibration instrumentation.
- Manages shipment and logistics for calibrated instruments and standards sent off-site for calibration and/or repair. Follows up with vendors to ensure timely return of equipment.
- Ensures visitors/contractors abide by procedures and policies while on site, including gowning requirements and good documentation practices.
- Reviews calibration worksheets and certificates provided by external service providers for completeness and accuracy and maintains database documents both hard copy and electronically within the Blue Mountain Regulatory Asset Manager (BMRAM) System. Uses Microsoft Excel to manage initial instrument asset record prior to final entry into RAM system.
- Ensures OOT events are report in a timely manner and that all necessary documentation is available to facilitate closure of the associated deviation investigations.
- Minimum: Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.
- Minimum: 0-3 years of relevant industry experience.
- Preferred: 4-6 years of experience working in an IVD GMP/ISO regulated environment.
- Possesses excellent people skills with ability to build effective internal/cross-functional relationships.
- Strong desire to work in a highly regulated environment, with diligent attention to detail to ensure laboratory areas meet regulatory, safety and departmental requirements.
- Basic working knowledge of Microsoft Office Suite and overall comfort and general familiarity with computer systems.
- Ability to demonstrate basic problem-solving skills.
- Ability to learn and follow routine procedures independently as well as part of a team.
- Comfort and flexibility to work in a changing environment.
- Ability to build and maintain positive working relationships with the business.
- Strong written and verbal communication skills.