JOB SUMMARY:

Write Standard Operating Procedures (SOPs), change controls, deviations, non-conforming material reports, and training materials for the department based on validated processes. Responsible for determining root cause, authoring and corrective actions associated with deviations and non-conforming material reports (NCMRs)

Transform technical and scientific ideas into simple language, so that average readers can easily understand.

Design, develop, and implement customized technical documents for use across a variety of teams. Gather information about needs, objectives, functions, and requirements. Conducts work assignments of increasing complexity, under moderate supervision with latitude for independent judgement.

Interview production, maintenance and engineering personnel to become familiar with product technologies and production methods. Observe production and experimental activities to determine work instructions, as well as what type of documentation may be needed for personnel training.

Requires effective planning, scheduling, researching, and writing skills. Career-development professional within field. 

CORE JOB RESPOSIBILITIES:

• Responsible for identifying documentation needs across maintenance, production, quality, and engineering teams. Design and manage independent projects, communicating project updates to key team members on a regular basis.
• Responsible for the creation, writing and/or editing of procedures, SOPs, deviations, non-conforming material reports, and change control documents.
• Responsible for coordinating deviation and non-conformance investigations. Work with subject matter experts to assign root cause and corrective actions for deviations and non-conforming material reports.
• Responsible for overseeing documents through the quality review process, ensuring reports are approved by key subject mattre experts and regulatory personnal prior to final submission.
• Illustrate technical or scientific concepts using photographs, drawings, sketches, diagrams, and charts. Study drawings, specification, and equipment in order to draft operating procedures, work instructions, or report justifications in detail.
• Identify trends in the manufacturing process based on reports related to product quality (such as deviations and NCMRs). Collaborate with other teams to track key information and create trend reports as needed.
• Organize material and complete writing assignments according to set standards regarding clarity, conciseness, style, and terminology. Edit, standardize, or make changes to material prepared by others.
• Interview production, maintenance, and engineering personnel to become familiar with product technologies and production methods. Observe production and experimental activities to determine work instructions, as well as what type of documentation may be needed for personnel training. 

Here’s some highlights of what we have to offer:

• Set Weekly Schedules with Consistent Work Hours
• Climate Controlled Environment
• Company Paid Uniforms
• 3 Choices of Medical Insurance Coverage
• Dental Insurance
• Vision Insurance
• Flex Spending Programs
• 401k with Company Match
• Company Paid Life Insurance
• Company Paid Short and Long-Term Disability
• Paid Time Off (Vacation, Sick, Holidays), 2021 includes additional COVID Hours
• Monthly Employee Treats and Lunches
• Tuition Reimbursement Program
• Gym Membership Reimbursement Program
• Incredible Employee Discounts on Medical Products

Education

• Bachelor of Science Degree or Bachelor of Arts Degree.

Relevant Work Experience

• At least two years' experience in Medical, Pharmaceutical, Manfacturing, or other field under regulatory compliance. OR
• At least one years' experience in Technical/Scientific Communication, Technical Writing, Regulatory Writing, or Medical Writing 

Knowledge/Skills/Abilities:

• Experience with Microsoft Excel and Microsoft Word.
• Experience with Adobe Acrobat Pro.

PREFERRED QUALIFICATIONS:

Additional

• Knowledge of FDA GMP compliant manufacturing is a plus.
• Experience with using Microsoft Visio is a plus.
• Experience with Adobe InDesign, Photoshop, and/or illustrator is a plus.
• Experience in training, teaching, or general instructional design is a plus.