1st Shift Documentation Control Specialist

Job Description

Job Description

Document Control Specialist

Job Summary:

This individual functions as part of the Document Control Team, a component of the larger Facility Quality function. They are primarily responsible for organizing, collating, reviewing,

coordinating corrections to, filing and archiving batch record documents. They will work directly with Quality, Operations and Warehousing functions to ensure that manufacturing records accurately reflect the history of Company products, and that any discrepancies in the records are identified and adequately addressed prior to closure of the record.

Primary Duties/Responsibilities:

• Review of batch and production records in addition to noting GDP errors

• To maintain planned and unplanned deviation reports from other departments

• To create and manage new and existing forms for plant operations and support

• Change controls – to oversee the change control process and insure its and accuracy and

completion with supporting documentation

• Collects and organizes specified data from various sources, which may include departmental heads and subject matter experts, surveys of reports and forecasts, personal observations, and other appropriate resources.

• Review collected data for paperwork related with the manufacture products, and other

documents that are critical for GMP (good document practices).

• Log, file and organize documentation systematically

• Creates detailed reports of data and analytical findings and clearly communicates them to management.

• Performs other related duties as assigned.

• Attention to detail and maintain teamwork skills

Required Skills/Abilities:

• Adept with basic research methods.

• Ability to think analytically.

• Mastery of basic math and statistics.

• Proficient in Microsoft Excel

• Ability to create visual descriptions of findings and present them to staff at varying levels in the organization.

• Ability to work independently.

• Ability to collaborate with the managerial staff of various departments.

• Excellent organizational skills.

• Understand and follow basic GDP (Good Document Practices)

Education and Experience:

• High School Diploma

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.

• Ability to navigate various locations and settings of the company.

Other Duties as required

Please note this job description is not designed to cover or contain a complete listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.