LL09-041924 Documentation Specialist

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Documentation Specialist for GMP Industry

Qualifications:

The Documentation Specialist will work with the Document Control Group Leader to achieve an efficient operation of the Document Control area, assisting area personnel as necessary. Coordinates with other departments to provide the necessary support to optimize Document Control activities. This position is responsible for providing technical written translation services between English and Spanish, as required.

Essential Job Functions:

• Work in conjunction of the Document Control Group Leader in the coordination of workload for efficient daily activities of Document Control department. May assume the Group Leader role in his/her absence.
• Performs the Gap Assessment of Corporate Standards that impacts Document Control procedures.
• Provides training for new employees and/or provides further training for other employees on new workstations.
• Coordinates official documents and Device Master Records changes.
• Serves a liaison between facilities regarding document changes and other matters.
• Follow up and resolve issues related to Device Master Records.
• Assures Device Master Record files actives are properly maintained.
• Initiate changes to documentation as required.
• Perform Document Control Department activities such as approve Administrative CR’s, Check-in, managing and distribution-controlled documents.
• Provides frequent assistance in person or over the telephone to internal and external customers. Meets with clients to discuss the document and clients’ needs.
• Serves a liaison between facilities regarding document changes and other matters.
• Translates documents, as required, ensuring that the meaning of the source text is retained.
• Supports the preparation of reports related to Document Control activities.
• Support Regulatory and Clients Audits in the scribe role.
• Contributes to team efforts by accomplishing business results as needed.
• Uses the required clothes, personal and security protective equipment according to the requirements of its operation.
• Complies with cGMP’s, Quality Standards and established policies and/or procedures.
• Assures is trained before performing any task.
• Executes other duties assigned by Supervisor.

Basic Qualifications:

• Should have good people skills with all levels of technical and operations personnel.
• Ability to complete position requirements with limited direct supervision.
• Ability to gather, organize information and ability to handle a variety of projects at the same time.
• Ability to grasp technical terms, processes, and methods.
• Should have Microsoft office skills, administrative writing skills and reporting skills.
• Demonstrate ability to complete assignments that are accurate, neat, and error-free, containing proper format, syntax, spelling, punctuation, and grammar.
• Must be bilingual (English/Spanish) and must have good communication skills both oral and written.
• Teamwork oriented.

Additional Desirable Qualifications, Skills and Knowledge:

• Knowledge of QSR and ISO, excellent computer skills, auditing, and reporting skills
• Must handle matters independently based on skills, knowledge of issues and prior directions.
• Must have good independent judgment and a demonstrated ability to set priorities.
• Be able to maintain multiple ongoing tasks on a tight deadline and work at a fast pace.
• Work cooperatively with co-workers and management.
• Ability to effectively deal with a wide variety of internal and external customers from executive staff to manufacturing/operations employees.
• Ability to work in a cross-functional team environment, as well as the ability to function independently.
• Prior experience in documentation control systems preferred.

Education and/or Experience:

• Bachelor’s Degree in business or Science.
• Two (2) to five (5) years of experience required in Quality Control or Quality Assurance in the Pharmaceutical or Medical Device Industry.