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Description

Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one.
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10,000 per calendar year
Onsite cafeteria with daily food stipend  

Position Summary:

Support site operations project development, change management process, and supporting documentation associated with products manufactured at the Durham site.  Provide documentation support for business-critical projects including design, startup and implementation of new equipment, facilities and processes. 

Primary Responsibilities:

Create and maintain Standard Operating Procedures (SOP) and Manufacturing Directions (MD) as a member of project and functional teams.Participate in planning, scheduling, and implementation of documentation deliverables for Nonconformance's (NC), Corrective Actions/Preventive Actions (CAPA), and Process Improvements.Communicate effectively and accurately with internal customers and management to ensure timelines are met and documentation is accurate and easy to understand.Participate in project planning activities, assessing necessary resources, and estimating timelines for documentation development and production.Research, write, and format user documentation according to approved styles and standards. Proofread documentation for accuracy and adherence to approved styles and standards.Compile reports, spreadsheets, and documentation as needed to support departmental workflow.Communicate with internal review teams to obtain approvals necessary for Change Requests.Track and implement change requests.Regularly interfaces with QA, QC, Manufacturing, Engineering, and other personnel to ensure that documentation concerns are timely resolved.Assist Quality Engineers in collection of paperwork for nonconformance investigations.

Education, Skills, & Experience:

Bachelor’s Degree preferred with 0 years Documentation experience in FDA regulated industry OR High School Diploma or GED with 3+ years Documentation experience in FDA regulated industryBasic Computer Skills required; must be experienced and proficient in the use of: Microsoft Office tools (specifically Word & Excel).Advanced use of MS Word preferred.Excellent documentation and communication skills (written & verbal). Position requires strong attention to detail, GDP and GMP experience.Ability to work successfully autonomously, as an active contributor on a team. 

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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).