Document Control Coordinator

Description

SUMMARY

The Document Control Coordinator provides documentation support to the Quality and Operations areas to ensure that all regulatory standards, guidelines, and procedures are met and followed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for master files, record keeping, updated specifications, data entry, and compliance within the MasterControl system.
• Creates Master Manufacturing Records in MasterControl from the production schedule to ensure that batch records are issued in a timely and accurate manner.
• Filing, maintaining archived documents, and inventory control of labels.
• Collaborates and consults with stakeholders to document subject material and technical specifications, and monitors user feedback.
• Examines documents such as SOPs, change orders, and specifications to verify completeness and accuracy of data.
• Works cross functionally to execute document change orders, coordinating change order, approval, release, and retention. 
• Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control procedures.
• Aids in the responses to internal and external audits 
• Reviews and approves Raw Material Supplier Documentation.
• Cross trains in other Quality functions as required.

Food Safety 

Responsible and required to notify management about actual or potential food safety issues; and empowered to act to resolve food safety issues within their scope of work. If this position is vacant for any significant period of time the obligation for completion of all food safety and quality related tasks will become the responsibility of the direct manager or a qualified designee.

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Skills/ Knowledge:

Possesses all basic and some advanced skills and knowledge. Has a thorough understanding of the total process flow.

Computer Skills: 

The ability to work effectively in a Microsoft Windows environment (Word, Excel, Outlook, and internal software programs), with advanced presentation skills and the ability to create and maintain spreadsheets. Experience formulating Excel spreadsheets from basic to complex formulas. Previous MasterControl experience is highly desirable.

Education:

High School diploma or general equivalency diploma (GED); with one to three years related experience and/or training; or equivalent combination of education and experience in a high-speed manufacturing environment. Experience in FDA regulations specifically related to food and GMP guidelines preferred.

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 this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee must frequently stand, walk, bend and twist, reach with hands and arms, climb, stoop, kneel. Regular fingering, grasping, and feeling: requires repetitive movement with frequent use of hands to handle, control, or feel objects, tools or controls and hand-eye coordination.
• The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and ability to adjust focus regularly.