Documentation Specialist

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 industry
• Basic 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.