QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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To support the Quality System Specialist - Documentation and Data Management in the receiving, storage and preparation of banker boxes of controlled documents to be delivered to outside storage.

Duties and Responsibilities:

• Maintains and coordinates documentation as required by the manufacturing facility such as Device Master Records, Device History Records, Customer Complaint Records, Forms Control System, Calibration Records, and other documentation activities as required.
• Performs quality record scanning and maintains electronic filing system per internal customer requirements.
• Maintains an accurate Master Record filling system.
• Ensure that all batch records are completed, and filed.
• Assist in the review of documents for completeness and accuracy.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.

KNOWLEDGE AND SKILLS:

• Knowledge of current regulatory requirements for pharmaceutical/medical devices industry.
• Knowledge on Documentation Control Systems.
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy.
• Demonstrated ability to follow established policies and procedures.
• Effective skills on interpersonal relationships, written and oral communication, planning/organization, time management, and proactive participation.
• Proficiency in the use of PC, scanner and office related equipment.
• Knowledge of current business systems and application software (MS Office or equivalent)
• Must be capable of independent work; a self-starter, highly motivated and able to work with minimal supervision.
• Bilingual (English and Spanish).
• Attendance and punctuality are an essential function of the job position.

 EDUCATION AND EXPERIENCE:

• Requires at a minimum an Associate Degree or equivalent with a minimum of one (1) year of experience in documentation control system in a FDA & ISO regulated environment.

• Candidates should send resume in Word format.