Pharma QA: Documentation & Compliance Specialist

Smart Media; Manassas (VA); On-site; USD 60,000 - 80,000; Full time

Job summary

Granules Consumer Health, LLC in Manassas is seeking a QA Associate for Documentation to ensure cGMP compliance and maintain controlled documents across batch records, CAPAs, and change controls. The role collaborates with cross-functional teams to review, approve, and archive documents, train new hires on GMP practices, and uphold SOPs.

The ideal candidate has a degree in sciences and at least two years of QA experience in a regulated environment.

Qualifications

• At least two years of QA experience in a cGMP environment.
• Degree in sciences such as Pharmacy, Biology, or Chemistry.
• Ability to analyze data and resolve quality issues.

Responsibilities

• Manage and maintain document control and archival systems in compliance with procedures and regulatory requirements.
• Route, review, approve, distribute and archive new and revised controlled documents.
• Track documents through issue numbers, logbooks, change requests, and status reports.
• Archive batch records, audit files, vendor files, product and label files, and change history files.
• Control and issue labeling components and maintain document control logs.
• Release finished product batches and provide training on GMPs and Pharmacovigilance.
• Ensure SOPs are reviewed for relevance and accuracy and collaborate to meet deliverables.
• Maintain version control and document issuance; support maintenance/closure activities of reports, deviations, CAPAs, and complaints.

Skills

cGMP compliance

cGMP documentation

Data analysis

Communication skills

Cross-functional teamwork

Prioritization

Education

Bachelor's degree in Sciences

Job description

Granules Consumer Health, LLC in Manassas is seeking a QA Associate for Documentation to ensure cGMP compliance and maintain controlled documents across batch records, CAPAs, and change controls. The role collaborates with cross-functional teams to review, approve, and archive documents, train new hires on GMP practices, and uphold SOPs.

The ideal candidate has a degree in sciences and at least two years of QA experience in a regulated environment.