Quality Assurance Technical Writer

Piper Companies; Ridgefield (NJ); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies in Ridgefield, NJ is seeking an experienced Quality Assurance Technical Writer to join a growing pharmaceutical manufacturer. The role focuses on authoring and revising QA documentation and Master Batch Records to support sterile injectable production.

Responsibilities include reviewing alterations to master batch records, advising manufacturing personnel on documentation standards, and ensuring compliance with FDA and GMP regulations using MS Office tools.

Qualifications

• 1-5 years’ experience in Pharmaceutical Manufacturing (sterile injectable preferred).
• Hands-on QA documentation experience.
• Proficiency in Microsoft Office.
• B.S. in business or scientific field preferred.

Responsibilities

• Review and author/maintain Master Batch Records and QA documentation.
• Correct and revise documentation as needed.
• Advise manufacturing personnel on proper documentation practices.
• Utilize knowledge of FDA and GMP regulations to ensure compliance.

Skills

QA documentation

Microsoft Office

Sterile injectable experience

GMP knowledge

Pharmaceutical manufacturing

Education

B.S. in business or scientific field

Job description

Piper Companies is currently looking for an experienced Quality Assurance Technical Writer in Ridgefield, New Jersey (NJ) to work for an innovative and growing pharmaceutical manufacturer.

Responsibilities for the Quality Assurance Technical Writer include:

• Review and act as author/technical writer to alterations to Master Batch record and QA documentation
• Correct and revise documentation as needed
• Advise manufacturing personnel on proper documentation
• Utilize knowledge of FDA and GMP regulations to ensure compliance

Qualifications for the Quality Assurance Technical Writer include:

• A minimum of 1-5 years’ experience within Pharmaceutical Manufacturing (sterile injectable is preferred)
• Hands on experience with QA documentation
• Proficiency in Microsoft Office
• B.S. in business or scientific field preferred

Compensation for the Quality Assurance Technical Writer include:

• Salary Range is dependent upon experience.
• Comprehensive benefits package

Keywords

Quality Assurance Technical Writer, QA, Pharmaceutical, Branchburg, NJ, New Jersey, FDA, GMP, Batch Record, Manufacturing, GDP, cGMP, Clinical Manufacturing, Regulatory Review, #LI-ONSITE #LI-DF1