QA Documentation Specialist – Entry Level

Virtue America; Massachusetts; Hybrid; USD 34,000 - 48,000; Part time

Benefits offered by this job

Hybrid work arrangement

Job summary

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.

Responsibilities

• 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.

Skills

Attention to detail

Organizational skills

Written communication

Microsoft Word

Microsoft Excel

Education

Bachelor's degree in Pharmaceutical Sciences

Tools

Microsoft Word

Excel

Job description

Job Title: QA Documentation Specialist – Entry Level

Location:

Massachusetts-hybrid

Employment Type:

Contract – W2 Only

Experience:

0–2 Years

Job Summary

We are seeking an Entry-Level QA Documentation Specialist to support quality assurance documentation and document control activities within a pharmaceutical, biotechnology, or life sciences environment. The ideal candidate will assist with preparing, reviewing, tracking, and maintaining controlled documents to ensure compliance with GMP/cGMP, FDA regulations, and Good Documentation Practices (GDP).

This position is suitable for recent graduates with a background in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related field who are interested in building a career in pharmaceutical quality assurance and compliance.

Key Responsibilities

• Prepare, review, organize, and maintain controlled quality documents, including SOPs, work instructions, forms, and quality records.
• Support document creation, revision, approval, distribution, archival, and periodic review processes.
• Verify documents for accuracy, completeness, formatting, and compliance with established procedures.
• Maintain document logs, revision histories, training records, and document control trackers.
• Assist with deviation reports, CAPA documentation, change controls, and nonconformance records.
• Ensure documentation follows GMP/cGMP and Good Documentation Practices (GDP).
• Support electronic document management systems and quality management systems.
• Coordinate document reviews and approvals with QA, QC, Manufacturing, Validation, Engineering, and Regulatory Affairs teams.
• Assist with audit preparation by retrieving and organizing controlled documents and quality records.Track overdue document reviews, pending approvals, and required employee training.
• Maintain accurate electronic and physical records while protecting document integrity.
• Support continuous improvement initiatives related to documentation and quality systems.

Required Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Biology, Chemistry, Microbiology, Life Sciences, or a related field.
• 0–2 years of experience in QA documentation, document control, quality assurance, or a regulated industry.
• Recent graduates and candidates with relevant internships or academic projects are encouraged to apply.
• Basic understanding of GMP/cGMP, SOPs, controlled documents, and documentation practices.
• Strong attention to detail, organizational skills, and written communication abilities.
• Proficiency in Microsoft Word, Excel, and other Office applications.