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Position Summary:Normal working hours for this role are anticipated to be Friday - Sunday 7:00am - 7:30pm. The Manufacturing Compliance Specialist will focus on Right First Time (RFT) initiativesReview of manufacturing documentation for compliance to GDP and CPP prior to submission to QAProvide on the floor document review of batch records and support for Manufacturing teamsEvaluate trend data for process improvementDeliver training to manufacturing teams on SOP/Process changesExecute document and process improvement changesTrack and Trend RFT metricsPrimary Responsibilities:Perform review of Manufacturing Documentation across multiple production lines
Ensure all Manufacturing Documents are fully reviewed before submission to the Batch Release GroupProvide on the floor document review and recommendations for error correctionsSupport manufacturing teams to provide feedback on error trends and area of focus
Record and maintain data to track batch record turnaround time, errors and document related deviationsTrack training activities and curriculums to ensure compliance is consistently maintainedPartner with Training, Industrialization, Engineering, Quality, Supply Chain and Manufacturing departments to provide detailed training on SOP and process changes to ensure compliance
Provide improvement ideas on documentation and processesComplete change control to ensure that improvement ideas are fully implemented. Partner with the investigation team to promote timely correction and closure of Non-ConformancesPerform any additional job related duties as requestedEducation, Skills, & Experience:HS diploma/GED and a minimum of 4 years experience in a regulated production/operations environmentAssociate degree (or higher) & 2 years experience in a regulated production/operations environmentExperience in FDA regulated environment with knowledge of Good Manufacturing PracticesExperience in Batch Record review in a regulated production/operations environmentExperience in continuous improvement, project management and delivering of training preferredAbility to translate written instructions, work orders and specifications.Knowledge of FDA and/or GMP regulations requiredQuality documentation review in production facility preferred.Excellent interpersonal skills and ability to work with all levels of an organizationAbility to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demandsMust be able to work effectively in a team based and individual environment.Must be able to deliver negative and positive feedback effectively.  Must hold to the highest level of accountability and integrityKnowledge of Microsoft Word, Excel, PowerPoint and Outlook required.  
SAP experience preferredStrong analytical and problem-solving skills.  Leadership experience preferred #biojobs

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).