PURPOSE

The Document Control Specialist is an individual contributor who organizes, files and controls cGMP documentation in accordance with company standards. This position is a key role to ensure product and quality system documentation meets the defined quality standards and worldwide regulatory requirements. This position also supports all documentation activities for change control, and specification management.

DUTIES AND RESPONSIBILITIES

• Manages Intelliguard’s document control and change management process ensuring proper document number assignment, initiation of change orders, timely review and approval, release/publication, and distribution of controlled documents.

• Support Intelliguard’s medical device and non-medical device documentation and processing accordingly.

• Communicates and facilitate changes impacting contract manufacturers.

• Performs general filing and record keeping for all quality documents and records electronically and physically.

• Supports quality reviews and audits associated with document control procedures.

• Performs other quality related duties as assigned.

QUALIFICATIONS

• Bachelor’s degree in science or related field (Biology, Chemistry, Physics, Engineering)

• Minimum 2-5 years’ relevant document control or quality experience in an FDA regulated facility.

• Excellent written and verbal communication skills

• Proficient in Microsoft Word, Excel, PowerPoint

• Strong teamwork skills

• Strong critical thinking and decision-making skills

WORKING CONDITIONS

The essential functions of the job are usually performed in an office setting, where the noise level in the work environment is typically low to moderate.

While performing the job duties, the employee is regularly required to sit, reach with hands, arms, talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus. 

SALARY

$33-$38/hr. Dependent on experience.