USA - Document Control Specialist I

Document Control Specialist I

Hours: 8am - 4:30pm
ONSITE Position - local candidates preferred

SUMMARY:
Responsible for providing clerical and administrative support for Quality Assurance documentation systems under current Good Manufacturing Practices (cGMP). Main responsibilities include electronic archival of Manufacturing Device History Records (DHRs) including scanning verification archival and transfer of DHRs according to established procedures. Operation of a desktop computer using word processing software and document scanning equipment with applicable software are required competencies

ESSENTIAL FUNCTIONS:
Assist the Quality Assurance function with Record archival storage and destruction while ensuring compliance with established regulations and standards.
Preparation of DHR records including removal of staples ensuring accurate pagination and compilation of Device Serial Number and Software Version information for transfer to Global Servicing Platform (GSP) as needed.
Scanning of DHR records using dedicated equipment with applicable software to produce a true copy .
Verification of scanned copies as true copies i.e. verified to be clear complete and legible.
Perform record archival or destruction according to the Records Retention Schedule and/or established procedures.
Assist in troubleshooting of document scanner related issues.
Maintain Document filing and archiving including filing of records checked in to Document Control and transfer of filed records to offsite storage as needed.
Perform other duties as assigned

QUALIFICATIONS KNOWLEDGE AND SKILLS REQUIRED
Must have basic knowledge of office equipment.
Working Knowledge of computer operations and a familiarity with applicable software packages (Microsoft Office Suite)
Verbal and written communication skills
The ability to pay attention to detail and prioritize workflow is essential.
Strong Organizational skills
Ability to multitask and perform tasks efficiently with little or no supervision.
Ability to identify errors or faults in the process and escalate issue to appropriate personnel when necessary.
Able to demonstrate responsiveness to customer needs within job scope.
Ability to follow specific directions and complete routine tasks within provided guidelines.

EDUCATION/EXPERIENCE REQUIRED
High School diploma or equivalent.
Minimum one (1) two (2) years office experience.
Basic computer and word-processing skills.
Clerical Skills are desirable.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee:
Must be able to sit stand bend stretch and walk throughout the workday
Must be able to lift at least 25 lbs
Work well under tight deadlines

WORK ENVIRONMENT
The work environmental characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas.
Work in close proximity to other employees.
Work in an environment that is temperature and humidity controlled.