Address
Form of workJob Description
Job Description
Date
02/2024
Location
1300 Airport Road, North Brunswick NJ
Title
Specialist, Quality Assurance Documentation
Department
Quality Assurance
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 the 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.
- Writes, reviews, and updates the SOPs relating to documentation collection and storage.
- Keeps up to date with the regulatory requirements around documentation and implements changes if necessary.
- Works with internal teams to obtain an in-depth understanding of the processes and documentation requirements.
- Organizes, writes, and maintains operational procedures and/or manuals for a variety of topics.
- Performs quality assurance on existing documentation.
- Revises outdated documents and ensure that all staff are using the correct version.
- Other Duties as Assigned
Other Responsibilities Including Safety:
- Complies with all job-related safety and other training requirements.
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 a 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.
