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Title

Document Control Coordinator II 

Category Quality Assurance  
Description

Primary Objective of Position

The Document Control Coordinator II is primarily responsible for managing documentation and change control processes and for assuring cGMP compliance of documentation. Document Coordinator II can perform all activities assigned to Document Coordinator I and will perform these activities as necessary to support the site.

Major Duties/Responsibilities

· Assist the release function by assigning SAP numbers, controlling the Excel wordsheets for data that is tracked for the annual product review.

· Review all documents and where correct formats. Start approval process for documents or reject and send back to the author for corrections. Prepare reports in Veeva as necessary to assist quality

management. Assure that all documents are placed on the Sharepoint portals for customers as required by the change control process and prepare memos for notification or approval; assure all completed complaints are placed on the portals and notify customer of their location.

· Issue to all affected departments notifications of approved change controls; close tasks with supporting documentation and circulate for review and/or closure. Maintain list of change control tasks and their status.

· Assist QA management in handling customer, corporate and FDA audits by taking notes, providing documents, tracking documents provided and other activities as needed. Set up the electronic audit folders for each individual audit and assure documents are transferred appropriately and available to the auditors. Arrange for a final copy of this folder for the audit file.

· Preserve historical files for all documents. This includes maintaining both on-site and off-site files; requesting files from off-site as required and destroying documents as per the retention schedule. Destruction of documents is done under the supervision of QA management. Assist departments in researching information and making copies of information.

· Coordinate meetings, if necessary, to resolve issues with changes.

 
Position Requirements

Minimum Job Qualifications

 

Education

 

High school diploma or general education degree (GED)

 

 

Experience

 

Minimum two years’ experience in the pharmaceutical environment, including experience in documentation creation and issuance. Working knowledge of cGMPs.

 

 

Knowledge/Skills/Abilities

 

·       Strong attention to detail

·       Effective office (clerical) time management, and organizational skills

·       Good time management skills

·       Ability to use own initiative and work independently

·       Strong computer skills and knowledge of word processing software and spreadsheet software

·       Act with professionalism and treat others with respect and consideration regardless of their status or position

 

Physical and Mental Demands and Work Environment

 

The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

 

Physical Demands

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is frequently required to stand and talk or hear; walk or sit; balance, stoop, kneel, crouch or crawl.

 

The employee is occasionally required to push, pull and lift various pieces of equipment. The employee must occasionally lift and/or move up to 25 pounds.

 

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

 

Mental Demands

While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; establish priorities and work on multiple assignments and projects concurrently.

 

The employee is regularly required to apply computer skills covering word processing and spreadsheet software.

The employee may be required to apply simple mathematical (addition, subtraction, multiplication, division). A high level of attention to detail is required and the employee must be accurate in the issuance and

performance of duties.

 

Work Environment

The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate.

 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.

New hires will pass a background check and drug screen as a condition of employment.  
EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.  
EmpID None Specified 


This position is currently not accepting applications.

To search for an open position, please go to http://Societal.appone.com



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