Pharma QA Records Reviewer (4-Month Assignment)

Ameri-partners; Indiana; On-site; USD 60,000 - 90,000; Full time

Job summary

Ameri Partners seeks an experienced Quality Assurance Specialist to support a short-term pharmaceutical project, focusing on QA review and approval of quality records within a Quality Management System (QMS). The role requires independent review of documentation, gap identification, and ensuring records are complete for progression.

The ideal candidate has hands-on QA experience in regulated life sciences and strong attention to detail, with ability to coordinate with Quality, Manufacturing, and

Qualifications

• Experience in quality assurance within a pharmaceutical/biotech or other regulated life sciences environment.
• Hands-on experience reviewing and approving documentation within a Quality Management System (QMS).
• Experience with quality records such as complaints, change controls, deviations, and related approvals.
• Strong understanding of documentation practices and QA oversight in a regulated environment.
• Ability to critically review records and identify deficiencies or inconsistencies.

Responsibilities

• Perform QA review and approval of records within the Quality Management System.
• Review and process product complaint records for completeness and appropriate resolution.
• Review Change Controls and associated documentation prior to QA approval.
• Review deviation records, including investigation documentation, impact assessments, conclusions, and follow-up.
• Review quality system documentation for completeness, consistency, and adherence to procedures.
• Provide QA oversight throughout applicable quality-system workflows.
• Identify documentation gaps and coordinate with record owners to resolve issues.
• Verify supporting documentation and approvals are included before records are closed or advanced in the QMS.
• Work with Quality, Manufacturing, Technical Operations, and other stakeholders to facilitate timely reviews.
• Support project priorities and backlogs while maintaining quality standards.
• Maintain accurate and timely completion of QA review activities.

Skills

QA experience

QMS

Documentation review

Cross-functional

Attention to detail

Tools

QMS software

Job description

Ameri Partners seeks an experienced Quality Assurance Specialist to support a short-term pharmaceutical project, focusing on QA review and approval of quality records within a Quality Management System (QMS). The role requires independent review of documentation, gap identification, and ensuring records are complete for progression.

The ideal candidate has hands-on QA experience in regulated life sciences and strong attention to detail, with ability to coordinate with Quality, Manufacturing, and