Documentation Coordinator (Avon)

NCW has an open position for a Documentation Coordinator. The qualified individual will assist the Quality Systems Supervisor/Manager with appropriate guidance and information within the facility for the administration and management of all documentation that falls under our client’s Quality System.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

This position is the key coordinating support position for all documentation that passes through the Quality Systems Process. The individual must have excellent organizational skills with a strong capability in oral and written communication. This position will indirectly report to and receive primary direction from the Quality Systems Manager.

1. Support archiving and auditing of Production Job Jackets (Records)

2. Routine maintenance of all Document Control System functions, including filing, routing, revising, distribution, and retrieving.

3. Revise, write, and route Work Instructions, SOP’s, and Forms.

4. Update documentation at the point of use as required, maintaining current and controlled documents on lines.

5. Maintain the Master list and Master Electronic files.

6. File, maintain, and organize all hard copies specifications and master files.

7. Lead/Assist in the quality system process activities involving customer complaints, CAPA’s, Deviations, Change Controls, Internal Audits, Job Jacket Review & site Quality training.

8. Assist in data collection and input for monthly metrics.

9. Assist in the oversight of all quality systems logs (ex. CAPA or deviation)

10. Data entry, auditing and submitting documents in the site electronic document management system

11. Assist in Quality Systems continuous improvement efforts

12. All other duties as assigned.

The above responsibilities are intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities, or requirements.

PERFORMANCE MEASUREMENTS

1. Report/Metric Timeliness

2. Accuracy of Reporting/Work

3. The success of Quality Systems Internal and External Audit Programs

QUALIFICATIONS

Education/Certification:

Bachelor’s Degree preferred

High School Diploma or equivalent required.

Required Knowledge:

Familiarity with cGMP’s

Knowledge of ISO standard (ISO 9001)

Experience Required:

3-5 years related administrative experience with computer and data entry experience.

Skills/Abilities:

Computer Skills and Information Technology (i.e. Microsoft Word and Excel)

WORKING CONDITIONS

None: No Hazardous or significantly unpleasant conditions.

The qualified candidate is encouraged to apply directly to this post. Thanks in advance for your interest!