Document Control Associate 1

The COOK Biotech Document Control Associate is primarily responsible for the administration of document change requests processed through the Quality Management System software application and ensuring compliance with applicable CBI instructions and procedures. This includes creating, managing, and implementing changes, as well as verifying implementation activities. Additionally, the Document Control Associate is responsible for monitoring and recording employee training, facilitating bi-weekly change request meetings, and support improvement initiatives for all quality system programs for continued compliance and improvement for training, change control, and document control.

• Create, process, monitor and ensure accuracy in both format and content for all document change requests
• Proofreads and types technical documents, letters and internal correspondence.
• Ensure departmental compliance with applicable CBI instructions and procedures as well as with agency standards and requirements for all areas of the quality system by managing the records of evidence of compliance.
• Serve as a point of contact for end user support with questions related to training, the change control process, and other Document Control functions.
• Remain engaged with document control processes and duties as well as current with new software application releases and technologies as they become available.
• Able to author Quality System Documents ensuring all regulatory guidelines are met as well as CBI compliance requirements.
• Facilitate bi-weekly change control committee meetings and ensure implementation activities are correctly assigned for all reviewed change orders.
• Records training on a timely basis and maintains paper training forms.
• Report deviations and other potential problems to QA management in a timely manner.
• Must be able to work independently.

• Decision-Making

• Knowledge

• Collaboration/Communication

• Change/Innovation

• Conduct other corporate duties as required.

• Proposes new ideas.
• Assist in meeting Corporate and Quality System goals.
• Is a positive and constructive participant in audits conducted by the FDA, Notified Bodies, and/or partners.
• Apply the understanding of job specific quality system processes to meet FDA Quality System Requirements and ISO 13485 in carrying out duties.
• Consults with supervisor and peers.

• Associate degree in Business Administration, Quality (or related field) or High School diploma with a minimum of two or more years’ experience in related field.
• Extensive knowledge of Microsoft Word including document formatting, use of styles, creation and use of macros, and developer tools.
• Ability to quickly assess, prioritize, and solve unique situations that may arise during the execution of daily tasks.
• Strong computer skills and excellent working knowledge of Windows Operating Systems and additional software applications including Excel, PowerPoint, Visio, Adobe Acrobat Pro, and web browsers including Explorer, Chrome, and Firefox.
• Excellent listening, writing and verbal skills expected of a BS/AS level education.
• Knowledge of regulated quality systems compliant to requirements such as 21 CFR 820 and ISO 13485.
• Able to handle multiple and changing priorities along with fluctuations in work load.
• Strong organizational and prioritizing skills.
• Understands the computer database systems at CBI including the production and inventory control systems.
• Able to work with multiple persons and the multiple priorities that occur when each person has different needs.
• Able to present a professional and personable demeanor in phone and in person.
• Familiarity with enterprise resource systems for Quality Management and/or document and change management.
• Strong attention to detail with exceptional proofreading and document review skills
• Familiarity with CBI products and processes, departmental responsibilities, and associated documentation a plus.

Physical Requirements/Work Environment

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Physical demands are typical of an office and classroom environment.
• Limited exposure to hazardous chemicals used in the manufacture of the product.