Quality Assurance Specialist — cGMP Batch Release

Adare Pharma Solutions; Huber Heights (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist to join the QA team. You will audit batch production documentation, support development, oversee contract manufacturing, and ensure disposition of product in accordance with cGMP.

Responsibilities include reviewing master and executed manufacturing records, handling deviations investigations, approving CAPAs, and interacting with customers while maintaining confidentiality and compliance with quality agreements.

Qualifications

• Bachelor’s degree preferred with 2+ years QA experience in pharma or GMP environments.
• Experience with a Quality Management System; Veeva preferred.
• Proficient in MS Office (Word, Excel, PowerPoint) desirable.
• Knowledge of cGMP related to records and documentation in bulk pharmaceutical manufacturing is preferred.

Responsibilities

• Review and disposition product documentation and batch records.
• Review Production, Packaging and Analytical records for compliance with procedures and specs.
• Investigate deviations and support CAPAs as needed.
• Approve master and executed manufacturing/packaging records.
• Interact with customers and maintain confidentiality; ensure quality agreements are upheld.
• Coordinate with CMOs to resolve deviations prior to lot disposition.
• Participate in internal audits and management reviews.

Skills

Quality experience

Veeva experience

MS Office proficiency

Education

Bachelor’s degree

Tools

Veeva

Microsoft Office

Job description

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist to join the QA team. You will audit batch production documentation, support development, oversee contract manufacturing, and ensure disposition of product in accordance with cGMP.

Responsibilities include reviewing master and executed manufacturing records, handling deviations investigations, approving CAPAs, and interacting with customers while maintaining confidentiality and compliance with quality agreements.