QA Documentation & Compliance Coordinator

Pine Pharmaceuticals; City of Tonawanda, Northern (NY, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Pine Pharmaceuticals is seeking a QA Document Control Associate in New York to support QA activities and maintain the Central File system. You will issue controlled documents, review batch records, and assist in MasterControl tasks while ensuring compliance with GMP and 21 CFR 210/211.

The role requires a high school diploma or higher with 1+ year in a regulated environment; proficiency in Excel and Word is essential, and experience with electronic QMS is preferred.

Qualifications

• Must have GMP knowledge and experience with controlled document filing.
• Experience in electronic Quality Management Systems is preferred.
• Proficient with Microsoft Office (Excel/Word) and document scanning.

Responsibilities

• Create and issue controlled documents (batch records, specifications, logbooks).
• Review batch production records for accuracy and completeness to ensure timely release.
• Confirm disposition of batch-associated nonconformances prior to release.
• Route documents for corrections and corrections follow-up.
• Use ERP to manage batch dispositions and distribution readiness.
• Support MasterControl document archival and collaborations.
• Maintain Central File system and readiness for audits.
• Assist QA activities and continuous improvement initiatives.

Skills

GMP knowledge

Document control

Attention to detail

Excellent communication

Independent work

Team collaboration

Education

High School diploma or equivalent

Associate/Bachelor in Science/Life Sciences preferred

Tools

Excel

Word

MasterControl

Job description

Pine Pharmaceuticals is seeking a QA Document Control Associate in New York to support QA activities and maintain the Central File system. You will issue controlled documents, review batch records, and assist in MasterControl tasks while ensuring compliance with GMP and 21 CFR 210/211.

The role requires a high school diploma or higher with 1+ year in a regulated environment; proficiency in Excel and Word is essential, and experience with electronic QMS is preferred.