Quality Assurance Specialist

Position

Quality Assurance Specialist

Vandalia, Ohio

The Quality Assurance Specialist is responsible for the audit of batch production documentation (manufacturing records, analytical records, deviation investigations), Development support, Contract Manufacturing oversight, disposition of product, approving quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.

• Audit Analytical testing and executed Batch Production Records.
• Review and approve Deviations and Lab Investigations.
• Coordinate and support Quality Assurance aspects of Product Development and Contract Manufacturing activities.
• Perform cleaning verification visuals and swabs.
• Release in-process materials for further processing and finished products for shipment.
• Interact with Customer’s Quality associates as necessary.
• Maintain and ensure correctness of documentation.
• Interface with all departments within the company.
• Ensure facility adherence to cGMP.
• Maintain the confidentiality of pertinent information.
• Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.
• Follow other job-related instructions and perform other tasks as required.
• Attends work on a regular and predictable basis.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Perform other tasks as required.

• Bachelor’s Degree preferred, with at 3+ years’ of Quality experience in a pharmaceutical or similarly regulated industry.
• Experience using a Quality Management System; experience with Veeva preferred.
• Experience with using 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.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.