QA Documentation & Compliance Associate

Granules Pharmaceuticals, Inc.; Manassas (VA); On-site; USD 55,000 - 65,000; Full time

Job summary

Granules Consumer Health, LLC in Manassas, VA seeks a QA Associate for Documentation to ensure cGMP compliance and support regulatory alignment. You will perform inspections, batch record reviews, and uphold quality systems in accordance with SOPs, state and federal laws.

Applicants should have at least two years in a quality assurance role within a cGMP environment and a Science-related degree. The role includes collaboration with cross-functional teams and involvement in documentation control

Qualifications

• cGMP compliance knowledge in pharma manufacturing.
• Proficiency in writing and maintaining cGMP documentation.
• Ability to analyze data to resolve issues.
• Strong verbal and written communication skills.

Responsibilities

• Manage document control systems and archival in compliance with procedures and regulatory requirements.
• Route, review, approve, distribute, and archive controlled documents.
• Track documents with control numbers, logs, change requests and reports.
• Maintain batch records, audit files, vendor files, labels and change histories.
• Control labeling components and document control logbooks/spreadsheets.
• Facilitate release of finished product batches for packaging.
• Provide new hire training on GMP, safety, and pharmacovigilance; maintain training docs.
• Ensure SOPs are current and relevant; collaborate to meet timelines.

Skills

cGMP compliance

Documentation writing

Data analysis

Verbal & written comms

Cross-functional collab

Multi-tasking

Education

Bachelor's degree in Sciences

Job description

Granules Consumer Health, LLC in Manassas, VA seeks a QA Associate for Documentation to ensure cGMP compliance and support regulatory alignment. You will perform inspections, batch record reviews, and uphold quality systems in accordance with SOPs, state and federal laws.

Applicants should have at least two years in a quality assurance role within a cGMP environment and a Science-related degree. The role includes collaboration with cross-functional teams and involvement in documentation control