Document Control cleark

JOB SUMMARY:

The specification/documentation personnel have the following primary responsibilities: Creating, issuing and storing all Master Document Files and all product documentation, data entry, developing written procedures for their area, and implementation of procedures and policies. He/she is also responsible for the receipt, inspection, and issuance of product labels.

ESSENTIAL FUNCTIONS:

• Perform all work in a safe manner
• Follow the training, instruction, and procedures provided by the Area Manager or Supervisor
• Pay attention to the work being performed
• Comply with all established procedures (GMP and SOP requirements).
• Meet established standards for quantity or volume of work required
• If using any type of equipment or machine, operate the machine as instructed and never change methods, tamper with controls, change settings, or do anything else that will affect the established process
• Be considerate of co-workers and visitors
• Keep the immediate work area clean and neat. 
• Practice good personal hygiene, avoid objectionable personal habits, wear uniforms, lab coats, hairnets and/or beard guards as designated, and use Personal Protective Equipment if required for the job
• Handle products, components and/or materials carefully and in a manner that does not cause contamination or damage.
• Ensure that any documentation is properly filled out in a timely manner and sent to the proper destination

SPECIFIC JOB ASSIGNMENTS

o   Issuing batch paperwork and all other applicable documents with the proper lot number

o   Create, update, and store Master Manufacturing Records, Batch Records, and all other quality documents per specific job SOPs

o   Issue product labels and reconcile returned labels in the label logs per SOPs

o   Receive, inspect and inventory all product label deliveries

o   Issue expiration dating for required products per SOPs

o   Perform QU Specification changes by the applicable SOPs

o   Maintain Raw Material and Vendor approval files per SOPs

o   Perform other duties as assigned

KNOWLEDGE, SKILLS, AND ABILITIES:

On the job training, job specific.

EDUCATION AND EXPERIENCE:

High school diploma preferred.