Quality Documentation Coord

PURPOSE AND SCOPE:

Updates logs and databases of product, manufacturing and regulatory compliance information. Coordinates the review and revision of procedures, specifications and forms. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under general supervision, follows established company policies and procedures.
• Maintain the integrity of working documents and update documentation when revised.
• Review manufacturing records.
• Prints release documentation.
• May refer to senior staff for assistance with higher level problems that may arise.
• Escalates issues to supervisor for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bending, carrying, kneeling, lifting, vision, hearing, sitting, maneuvering, pushing, and pulling, reaching, standing, stooping and walking.
• Able to lift 50 lbs. with assistance.

SUPERVISION:

• None

EDUCATION:

• High School Diploma required

EXPERIENCE AND REQUIRED SKILLS:

• 1 – 2 years’ related experience.
• Ability to follow Quality Assurance procedures.
• Experience using document management/records management software solutions.
• Self-motivate/self-starter, ability to carefully review documentation.
• Ability to be very organized with files and other documentation.
• Must be detail-oriented and thorough.
• Must pass a color vision screen.
• Strong oral and written communication skills.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors