What are the responsibilities and job description for the Document Control Specialist position at Branch 41?

Job Description

GENERAL DESCRIPTION : Facilitates the flow of information through the company and ensures quality of information. Actively seeks to increase the value of information by making it readily available, usable, and actionable. Regulates the control, distribution, retention, and archiving of cGMP documents. Ensures documentation is compliant with internal procedures as well as regulatory and statutory standards.

ESSENTIAL DUTIES / RESPONSIBILITIES / FUNCTIONS :

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

Writes, updates, issues, and maintains QA documentation including, but not limited to, SOP’s, Work Instructions, Forms, Technical Files, Master Manufacturing Records, Batch Records, Specifications, and other cGMPs related documents.
Develops new processes and improvements on existing quality processes.
Coordinates the change control process.
Coordinates periodic review of all Company SOP’s.
Identifies areas in need of process improvement in regards to efficiency and / or quality and makes changes following approved change control procedures.
Collaborates with subject matter experts as needed for SOP development.
Assists Quality Management in establishing, implementing and maintaining the quality management system.
Creates, updates, and maintains Master Manufacturing Records (MMRs) and Master Packaging Records (MPRs)
Functions as document control software administrator including controlling content type, document control numbers, user rights, and user groups
Reviews all new and revised controlled documentation for appropriate format, content, and consistency with other documentation.

MARGINAL JOB FUNCTIONS :

Comply with Company SOPs and Policies.

Assists in implementation of improved document management systems.

Provides request documents in hard copy or scanned for Regulatory, Auditors (internal and external).

Creates document status reports.

QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES :

Ability to read, speaks, and writes in English.

Ability to navigate document control software.

Good computer skills including Microsoft Office, and data entry in an ERP system.

Knowledge of basic office procedures.

Ability to operate office equipment including copy machine, fax, telephone, PC, and 10-key calculator.

Knowledge of technical writing to including process writing and document design.

Ability to understand and interpret regulations.

Understand and practice safety procedures and practices.

PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES :

Lift up to 15 lbs.

Sit, stand, kneel, twist, turn and stoop.

Use keyboard, computer and calculator.

Reach forward and overhead as needed.

Stand / remain upright for up to 4 or more hours at a time.

Sit up to 4 or more hours at a time.

EDUCATION AND / OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES :

Bachelor’s degree or a combination of 3 years work experience in a Quality Management position required.

Familiarity with Ensur a plus.

Company Description

Staff Force Personnel Services : 9786 Skillman St, Dallas, TX 75243

Hours of application : Monday- Friday 9am-2pm

Company Description

Staff Force Personnel Services : 9786 Skillman St, Dallas, TX 75243 Hours of application : Monday- Friday 9am-2pm

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Document Control Specialist

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