QA Documentation Specialist – Entry Level (Hybrid)

Virtue America; Massachusetts; Hybride; USD 34 000 - 48 000; Temps partiel

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Virtue America is seeking an Entry-Level QA Documentation Specialist to support quality assurance documentation and document control within a life sciences setting. The role involves preparing, reviewing, and maintaining controlled documents to ensure GMP/cGMP and GDP compliance.

Ideal candidates are recent graduates in life sciences and have a basic understanding of GMP concepts, strong attention to detail, and proficiency with Microsoft Word and Excel.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Biology, Chemistry, or Life Sciences or related field.
• 0–2 years of QA documentation or document control experience in regulated industry.
• Basic understanding of GMP/cGMP, SOPs and GDP documentation practices.
• Strong written communication and organizational skills.

Responsabilités

• Prepare, review, organize, and maintain controlled quality documents (SOPs, work instructions, forms).
• Support document creation, revision, approval, distribution, archival, and periodic reviews.
• Verify documents for accuracy, formatting, and compliance with procedures.
• Maintain document logs, revision histories, training records, and trackers.
• Assist with deviation reports, CAPA documentation, change controls, and nonconformance records.
• Ensure documentation follows GMP/cGMP and GDP.
• Support electronic document management and quality systems.
• Coordinate document reviews with QA, QC, Manufacturing, Validation, Engineering, Regulatory Affairs.
• Assist with audit preparation by organizing controlled documents and records.
• Track overdue reviews, pending approvals, and employee training.

Connaissances

Attention to detail

Organizational skills

Written communication

Microsoft Word

Microsoft Excel

Formation

Bachelor's degree in Pharmaceutical Sciences

Outils

Microsoft Word

Excel

Description du poste

Virtue America is seeking an Entry-Level QA Documentation Specialist to support quality assurance documentation and document control within a life sciences setting. The role involves preparing, reviewing, and maintaining controlled documents to ensure GMP/cGMP and GDP compliance.

Ideal candidates are recent graduates in life sciences and have a basic understanding of GMP concepts, strong attention to detail, and proficiency with Microsoft Word and Excel.