Quality Assurance Specialist

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

Project Duration: Approximately 4 Months

About the Opportunity

Ameri Partners is seeking an experienced Quality Assurance Specialist to support a short-term project within a pharmaceutical environment.

The primary focus of this assignment will be the QA review and approval of quality records within a Quality Management System (QMS). The ideal candidate will be comfortable independently reviewing quality documentation, identifying gaps or inconsistencies, and ensuring records are complete and appropriate for progression through the quality system.

Key Responsibilities

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

Required Qualifications

• Professional experience in Quality Assurance within a pharmaceutical, biotechnology, 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
• Quality system documentation and approvals
• Strong understanding of documentation practices and QA oversight within a regulated environment.
• Ability to critically review quality records and identify documentation deficiencies or inconsistencies.
• Strong attention to detail and ability to manage multiple quality records and priorities.
• Ability to work effectively with cross-functional stakeholders to resolve documentation and quality-system issues.

Candidates with experience supporting QA operations, quality systems, deviation management, complaint handling, change control, investigation review, and documentation approval in pharmaceutical or biotechnology organizations are particularly relevant for this project.