Document Control Specialist

summary

Revise QA-controlled documents, including Master Bulk and Packaging Records, SOPs, Forms, and other documents specified in SOPs. In addition, a key responsibility is the maintenance, storage, and archiving of all QA-controlled documents. Route documents electronically for review and approval and track their completion. Serve as Liaison between Document originators and departmental reviewers and approvers. Work with Training and Development to ensure appropriate notifications regarding training requirements are developed and administered. Update appropriate Master Indexes and Inform users when new and revised documents are available for use.

essential Duties and Responsibilities

• Draft and revise Master Bulk and Packaging Records, SOPs, forms, and other QA-controlled documents.
• Route and Track records through the review and approval process.
• Maintain master files for all Document Control Related Records.
• Ensure compliance to SOPs regarding development, control, maintenance, and issuance of Master Bulk and Packaging Records, SOPs and forms.
• Provide service to departments regarding documentation, including but not limited to, provide copies, collect data, and train on key document control procedures.
• Coordinate with the originating department to ensure Master Bulk and Packaging Records and SOPs are in current format/template and that the summary of change reflects the actual changes within the document.
• Notify Training and Development when documents are approved and available for training.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledgeable about Pharmaceutical Manufacturing Operations.
• PC proficiency using Microsoft Office suite and ability to type 65 WPM
• Outstanding oral and written communication skills.
• Detail oriented, meticulous in nature, with excellent proofreading skills.

EDUCATION/EXPERIENCE

• High school diploma or general education diploma (GED).
• Three years' broad GMP documentation experience; at least one year in an FDA-regulated environment.

Work environment

The physical demands described here are representative of those that must be met by an individual 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 individual is:

1. Frequently required to sit and/or stand, walk, talk and hear.
2. Constantly required to use hands and fingers to operate office machines and equipment.
3. Frequently required to reach with hands and arms.
4. Occasionally required to stoop, kneel and crouch.
5. Required to have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
6. Required to exert a negligible amount of force continuously and/or up to five pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.

1. Normal office conditions.

Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

• Eye protection (safety glasses).
• Foot Protection (steel or composite toe safety shoes).

Nesher is an equal opportunity employer

Current Openings for Document Control Specialist Jobs at Nesher Pharmaceuticals (USA) LLC