Associate, Quality Assurance Documentation
Description:
Job Description
Job Description
Date
06/2018
Location
1300 Airport Road, North Brunswick NJ
Title
Associate, Quality Assurance Documentation
Department
Quality Assurance
Reports to
Manager, Quality Assurance
FLSA (Exempt or Non-Exempt
Exempt
Role Overview
Level 1
The Associate, QA Documentation 1, will be responsible for the writing, distribution, collection, storage, and maintenance of our company’s documentation and includes tracking products, materials, status, and location.
Level 2
An Associate, QA Documentation 2, will be responsible for the writing, distribution, collection, storage, and maintenance of our company’s documentation and includes tracking products, materials, status, and location. Involved in the review of vendor and ingredient qualifications as well as the review and issuance of batch records. Participates in audit preparations and other compliance documents.
Level 3
An Associate, QA Documentation 3, will be responsible for the writing, distribution, collection, storage, and maintenance of our company’s documentation and includes tracking products, materials, status, and location. Involved in the review of batch records, vendor qualifications. Participating in audit preparations and other compliance documents.
Areas of Responsibility
Level 1
Responsible for daily tracking of raw materials, shipping, when results are returned, and daily status.
Responsible for ensuring products are shipped correctly and what needs to be sent out for testing.
Scan, file, fax, and organize documents for product specifications.
Organize product specific documents, compliance documents.
Acting as a point of contact for retrieval of specific documentation as required
Write, review, and update the compliance documents.
Other Duties as Assigned
Level 2
Responsible for daily tracking of raw materials, shipping, when results are returned, and daily status.
Responsible for ensuring products are shipped correctly and what needs to be sent out for testing.
Scan, file, fax, and organize documents for product specifications.
Organize product specific documents, compliance documents.
Acting as a point of contact for retrieval of specific documentation as required
Write, review, and update the compliance documents.
Other Duties as Assigned
Level 3
Responsible for the review and issuance of batch records
Coordinate Finished Product release
Able to prepare material based on specifications
Reviews the release of material and products, vendors, and ingredient qualifications
Responsible for daily tracking of raw materials, shipping, when results are returned, and daily status
Involved in audit preparations and review of compliance documents
Conducts retrieval of logbooks and other GMP records
Responsible for ensuring products are shipped correctly and what needs to be sent out for testing
Organize product specific documents, compliance documents
Acting as a point of contact for retrieval of specific documentation as required
Write, review, and update the compliance documents.
Other Duties as Assigned
Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Keeps management informed of area activities and of any significant problems.
Requirements
Education & Qualification:
Level 1
Bachelor’s Degree preferred.
1-2 years relevant document experience
Level 2
BS/BA degree preferred.
2-4 years relevant document experience
Level 3
BS/BA degree preferred.
3 - 5 years relevant document experience
Certifications, Licenses, Credentials:
N/A
Skills & Ability
Demonstrates ability to work in a team and assist others.
Able to follow written instructions precisely and perform basic math calculations as required.
Attention to detail and accuracy with numbers.
Understands and is knowledgeable of cGMP, OSHA standards etc.
Must be able to distinguish different shades of colors.
PC-based computing experience (Word, Excel)
Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP’s, GLP, documentation) when performing the assigned activity.
Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.
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
Full-time