Quality Assurance Specialist – GMP Batch Release & Compliance

Adare Pharma Solutions; Vandalia (OH); On-site; USD 60,000 - 90,000; 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 approve quality documents to ensure cGMP compliance.

The role requires a bachelor’s degree and 2+ years in pharmaceutical quality, experience with QMS (Veeva preferred), and strong attention to detail with document control.

Qualifications

• Bachelor’s degree preferred with 2+ years quality experience in pharmaceutical manufacturing or GMP environment.
• Experience using a Quality Management System; Veeva experience preferred.
• Microsoft Office Suite (Word, Excel, PowerPoint) experience preferred.
• Knowledge of cGMP related to records and documentation in bulk pharmaceutical manufacturing.
• Knowledge of large processing systems and related equipment is highly preferred.
• Accuracy and neatness in compiling documents.

Responsibilities

• Disposition Product and review production, packaging, and analytical records for compliance.
• Resolve documentation issues as directed by SOP and escalate major issues.
• Conduct product release activities including master and executed batch records review.
• Investigate deviations and ensure proper documentation.
• Approve CAPAs and maintain quality system integrity.
• Interact with customers and ensure adherence to Quality Agreements.
• Support customer service activities related to quality and regulatory.
• Maintain confidentiality of sensitive information.

Education

Bachelor’s Degree preferred

Tools

Quality Management System (QMS)

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 approve quality documents to ensure cGMP compliance.

The role requires a bachelor’s degree and 2+ years in pharmaceutical quality, experience with QMS (Veeva preferred), and strong attention to detail with document control.