Specialist, Documentation

Job Description

Job Description

Job Description

Date

04/2020

Location

1300 Airport Road, North Brunswick NJ

Title

Specialist, Quality Assurance Documentation

Department

Quality Assurance & Regulatory

Reports to

Manager , Quality Assurance/

Head of Quality Assurance

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

A Specialist, QA Documentation will be responsible for the writing, distribution, collection, storage, and maintenance of our company’s documentation.

This position will help ensure compliance to SOPs, GMP documentation and to 21 CFR Part 111 and 117.

This position Reports to the Quality Assurance Manager and dotted line to Head of Quality Assurance.

Areas of Responsibility

• Creates documentation that meets the regulatory requirements before distributing through the company to implement.
• Acting as a point of contact for retrieval of specific documentation as required.
• Write, review, and update the SOPs relating to documentation collection and storage.
• Keeps up to date with the regulatory requirements around documentation and implements changes if necessary.
• Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements.
• Organize, write, and maintain operational procedures and/or manuals for a variety of topics.
• Perform quality assurance on existing documentation.
• Revise outdated documents and ensuring that all staff are using the correct version.
• Other Duties as Assigned

Other Responsibilities Including Safety:

• N/A

Requirements

Education & Qualification:

• Bachelor’s Degree preferred
• 2-4 years administrative experience

Certifications, Licenses, Credentials:

• N/A

Skills & Ability

• Demonstrated above average written communication skills in the English language
• Must be advanced with all MS Office software, must have excellent typing skills
• The ability to interact with department heads regarding corporate compliance
• Ability to maintain professional and positive attitude
• Ability to manage multiple tasks effectively & efficiently
• Possess high-level of ethics and integrity
• Must be able to keep information confidential.

Physical Requirements (lifting, etc.):

• The employee is frequently required to sit (50%), stand, and walk (50%); use of hands to finger, handle or feel writing tools and computer keyboard; may reach with hands and arms and infrequently may lift up to 30lbs.; uses desk telephone/cell phone to talk and hear or converses with other employees.

Work Environment (Office, Warehouse, temperature extremes, etc.):

• Primarily located in an office environment where temperatures are controlled for heat and air conditioning; occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

USPL is proud to be an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.