· Job facts
Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for calibration. Performs calibration and evaluation of internal controls, communications, and periodic review of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies and evaluates deficiencies, failures, and /or risks while working with internal departments/business units to appropriately remedy them. Responsible for coordinating and managing calibration activities, including scheduling, technical data review and reviewing, approving work records, and performing evaluation of internal controls. May assist with preparing metrology investigations, summaries and reports and analysis.
Applies advanced knowledge and skills to complete assignments requiring judgement and initiative. Understands implications of work and makes recommendations for solutions. Receives little instruction on daily assignments and may determine methods and procedures on new assignments.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
What you do
· Calibrate instruments and troubleshooting, installing and repairing mechanical components, as well as, working closely with electrical apparatuses.
· Identify measurement errors and contributing factors that may result inaccurate measurements.
· Initiates Out of Calibration Reports (OCRs) for failing instruments.
· Ships, Tracks, and Receives deliverable instrumentation.
· Processes calibration documentation within the calibration database.
· Perform administrative tasks related to calibration including but not limited to scheduling internal calibration activities/repairs.
· Performs technical data review for conformance to quality parameters and specifications.
· Review of GDP calibration documentation.
· Processing new equipment into Maintenance Asset Management Software.
· Technical SME for metrology.
· Review/approval of calibration work records.
· Develops calibration SOPs and test methods for new instruments that facilitates in-sourcing of calibration.
· Performs evaluation of internal controls, communications, risk assessments
· Periodic review of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
· Identifies risks and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
· Schedules calibration activities, resources and repairs with external vendors as well as escorting said vendors for on-site visits.
· Coordinates with Validation and Project Management teams to ensure calibration resources are available to support project execution.
· Maintains and/or buys the calibration supplies for the calibration of instruments within the lab.
· May lead technical support in trouble shooting, capital projects, design and process improvement projects.
· May perform audits and risk assessments.
· May serve as a backup or proxy to the Metrologist.
Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Ideal candidate profile
Who you are
· High school diploma plus minimum of 8 years prior experience in calibration of equipment OR Associate's degree plus 6 years prior calibration experience
· Understanding of basic statistics
· Strong computer and math skills
· Proficient with Windows, Microsoft Office, and Internet applications with an emphasis on Excel
· Good customer service skills
· Excellent attention to detail
· Excellent organizational skills
· Capable of lifting (50 pounds) unassisted
· Bachelor's or Associate's degree in a technical field preferred
· Military service in calibration field highly regarded
· One year of metrology review and/or quality documentation review
· Experienced and aware of ISO 9000 and/or ISO 17025 quality assurance program desired