Documentation Control Associate

Sharp Services•Allentown, PA

1d•Hybrid

About The Position

The Documentation Control Associate is responsible for maintaining the SOP harmonization process between both sites, maintaining an updated Training database for both facilities, handling the entire SOP (Standard Operating Procedure) process, and maintaining the component specification process. This role requires excellent attention to detail, strong organizational skills, and the ability to manage documentation with potential regulatory and financial impact on the company.

Requirements

General knowledge of DEA 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.
Ability to respond to common inquiries from external customers and the ability to respond to inquiries from peers and superiors.

Nice To Haves

General knowledge of FDA regulations.
Experience in pharmaceutical or related industry is desired.
College degree is preferred.
One to two years related experience and/or training; or equivalent combination of education and experience is preferred.

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 check.
Assist Quality Assurance department during customer and governmental audits.