Pharma QA Specialist — cGMP Compliance & Batch Release

Adare Pharma Solutions; Vandalia (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist responsible for auditing batch production documentation, development support, and ensuring cGMP compliance across manufacturing and packaging records.

You will review master batch records, participate in deviations investigations, approve CAPAs, and interact with CMOs and customers to maintain quality standards.

Qualifications

• Bachelor’s Degree preferred, with at least 2 years of QA experience in a pharmaceutical or GMP regulated industry.
• Experience using a Quality Management System; experience with Veeva preferred.
• Experience with the Microsoft Office Suite of software (Word, Excel, PowerPoint) is preferred.
• Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.
• Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems is highly preferred.
• Accuracy and neatness of compiling documents.
• Attention to detail.

Responsibilities

• Disposition Product
• Review executed Production Records, Packaging Records and Analytical results for compliance with procedures and specs
• Resolve documentation issues per SOP
• Conduct product release activities for intermediates, drug product and finished goods
• Investigations and deviation handling
• Approve Corrective and Preventive Actions (CAPAs)
• Interface with customers and ensure quality agreements compliance
• Support customer service-related activities
• Maintain confidentiality of information
• Review and approve master and executed manufacturing/packaging records
• Collaborate with CMOs to resolve deviations before lot disposition
• Participate in internal audits and trainings
• Be an ambassador for Quality across departments
• Ensure facility adherence to cGMP

Skills

Quality Management System

Veeva

MS Office

cGMP knowledge

Attention to detail

Education

Bachelor's Degree

Tools

Quality Management System

Veeva

MS Office Suite

Job description

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist responsible for auditing batch production documentation, development support, and ensuring cGMP compliance across manufacturing and packaging records.

You will review master batch records, participate in deviations investigations, approve CAPAs, and interact with CMOs and customers to maintain quality standards.