Quality Assurance Specialist — Ensure Batch Compliance & Release

Adare Pharma Solutions; Dayton (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, Ohio, is seeking a Quality Assurance Specialist to audit batch production and review manufacturing, analytical, and deviation records, ensuring cGMP compliance.

You will support development and contract manufacturing oversight, approve quality documents, participate in investigations, and interact with customers while maintaining confidentiality and adherence to Quality Agreements.

Qualifications

• Bachelor’s Degree preferred with 2+ years of quality experience in pharma or GMP environments.
• Experience using a Quality Management System; Veeva preferred.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge of cGMP related to records and documentation.

Responsibilities

• Review and disposition batch production records and associated documents.
• Conduct product release activities for intermediates, drug product and finished goods.
• Investigate deviations and ensure proper documentation.
• Interact with customers and maintain confidentiality of information.
• Audit support and participation in internal audits.

Skills

Quality experience

Regulatory compliance

Documentation practices

Attention to detail

Education

Bachelor’s Degree preferred

2+ years GMP quality experience

Tools

Quality Management System (QMS)

Veeva

Microsoft Office

Job description

Adare Pharma Solutions in Vandalia, Ohio, is seeking a Quality Assurance Specialist to audit batch production and review manufacturing, analytical, and deviation records, ensuring cGMP compliance.

You will support development and contract manufacturing oversight, approve quality documents, participate in investigations, and interact with customers while maintaining confidentiality and adherence to Quality Agreements.