Want to see more? Find all job opportunities for both BioFire and bioMérieux worldwide by clicking here.
Description
This is a full-time, hourly position that provides support through inspection of raw materials. As a Quality representative, the employee will assess and monitor both process and product. Timely and accurate work as well as a high level of self-direction and motivation is expected. Regular cross functional interaction and collaboration with attention to detail is required. Work is fast paced and requires prioritization of daily tasks. Effective communication, written and verbal, is critical.
Description
Perform all work in compliance with company policy and within the guidelines of its Quality System.Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)May present project related information to management as requested.Perform inspection of incoming materials using basic and advanced measurement toolsPerform quarantine activities including physical and electronic segregation, labeling, physical and electronic releaseInitiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejectionComplete first article inspections.Perform and manage sorting activities to completionIdentify need for WID updates and initiate WID updatesSupport and/or manage validation testing, e.g. GR&R and program validation activities.Initiate and author IC documents (Inspection plan)Support/interact with Materials Management, Engineers, Purchasing, and suppliers. This includes research activities and special projects.Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditorReview co-worker completed inspection recordsMentor techniciansInitiate routines and programs for metrology tools under engineer guidanceCoordinate activities for metrology tool calibrationEnsure compliance to Temporary Change Orders; manage expiration status Interpret and utilize SPC chart data Analyze trends and participate in metrics development Participate as a subject matter expert in internal and external audits of the Incoming Inspection team. Write validation protocols Input data into MiniTab and work with Engineering on analysis of validation data
Training and Education
High school diploma or equivalent is requiredAssociate degree (or higher) in a life science or engineering discipline is preferred.Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is requiredEnrollment in the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree) is preferred.
Experience
Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of 1-year of this experience5 years combined above experience is preferred
Skills & Qualifications:
Preferred specialized expertise such as IPC610 and/or IPC620 certified, GD&T background, problem solving, technical writing, black belt.Effective written and verbal communication skillsProficiency in MS Office tools, including Outlook, Word, and ExcelGeneral computer operationAttention to detail is fundamental to this position.Ability to accurately follow written and verbal instructions.Organization skills as needed to maintain paperwork and task schedule.Proficiency in internet navigationBasic math proficiencyAbility to write standardized and clear instructions
Demonstrated skill set and knowledge of inspection methodologies and techniques assessed through competency testing during the interview process.
Physical Requirements:
Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibilityMust be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).