Regulatory QA Documentation Specialist

US Pharma Lab; North Brunswick Township (NJ); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Short and long term disability

Basic life insurance

Supplemental life insurance

AD&D insurance

Matched 401(k) savings plan.

Premium pay (overtime, shift diff)

Job summary

US Pharma Lab in North Brunswick, NJ, is seeking a Specialist, Quality Assurance Documentation to write, distribute, collect, store, and maintain our documentation. This role ensures compliance with SOPs, GMP documentation, and 21 CFR Parts 111 and 117, reporting to the QA Manager with a dotted line to Head of QA.

You will coordinate with internal teams to understand processes, author and update SOPs, perform QA on documents, and ensure staff use current versions.

Qualifications

• 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.

Responsibilities

• 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• Revise outdated documents and ensuring that all staff are using the correct version.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

Skills

Written communication

Interdepartmental coordination

Confidentiality

Multitasking

Professional attitude

Ethics and integrity

Education

Bachelor's Degree

Tools

MS Office

Job description

US Pharma Lab in North Brunswick, NJ, is seeking a Specialist, Quality Assurance Documentation to write, distribute, collect, store, and maintain our documentation. This role ensures compliance with SOPs, GMP documentation, and 21 CFR Parts 111 and 117, reporting to the QA Manager with a dotted line to Head of QA.

You will coordinate with internal teams to understand processes, author and update SOPs, perform QA on documents, and ensure staff use current versions.