QA Documentation Associate

Summary:

The major function of this job include:

• Maintain the SOP harmonization process between both sites.
• Maintain updated Training database for both facilities.
• Handle the entire SOP (Standard Operating Procedure) process.
• Maintain the component specification process.
  
  

Specific Duties and Responsibilities:

• Assist in the SOP harmonization project for multiple Sharp facilities.
• Create, revise and obsolete SOPs and coordinate those activities with Managers and Directors in both sites.
• Responsible for ensuring SOPs approval process is streamlined and current.
• Work with IT to ensure SOPs are posted on Sharp intranet and the necessary security surrounding their control.
• Create, revise and obsolete component specifications.
• Responsible for entering and maintaining individual training files for all Sharp employees for both facilities.
• Update SOP table of contents, distribute SOPs and update appropriate QA folders and Audit Packet for both facilities.
• Send notices for required training to all Sharp departments.
• Maintain temporary agencies employees Master Signature Log page and for all permanent employees.
• Keep track of all permanent employees’ background checks.
• Assist Quality Assurance department during customer and governmental audits.
• Other duties may be assigned as appropriate.
  
  

Supervisory Responsibilities:

No direct supervision. Candidate’s personal decisions can result in compliance decisions that may have regulatory and financial impact on the company.

Education and Experience Requirements:

• A High School Degree is required. College degree preferred; however, experience and college courses may be substituted for the degree. One to two years related experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• General knowledge of DEA (required) and FDA (plus) regulations.
• Excellent detail skills as they apply to documentation review and compliance.
• Good written and oral communication and interpersonal skills
• Good organizational and planning skills
• Out-going, assertive and detail-oriented person
• Knowledge of Microsoft Office Suite and Excel
  
  

Language Skills:

Possess the ability to respond to common inquiries from external customers and the ability to respond to inquiries from peers and superiors.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing 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 employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.