Quality Assurance Specialist

Adare Pharma Solutions Recruiting Team•Vandalia, OH

20h•Onsite

About The Position

The Quality Assurance Specialist is a key player on the Quality Assurance team, 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 overall adherence to cGMP.

Requirements

Bachelor’s Degree preferred, with at least 2+ years of Quality experience in a pharmaceutical or other GMP 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.
Attention to detail.

Responsibilities

Disposition Product
Review executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards
Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP and resolves major issues that are not defined by SOP.
Conduct product release activities for intermediates, drug product and finished goods including review and approval of master batch records and executed batch records.
Ensure deviations are properly documented and investigated.
Approve Corrective and Preventive Actions.
Ensure compliance with Quality Agreements.
Support customer service-related business activity, as appropriate.
Maintain the confidentiality of pertinent information.
Review and approve master and executed manufacturing / packaging records.
Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.
Actively participates on project teams as assigned by management.
Completes all assigned training by target due dates.
Participates in internal audits as assigned by management.
Interface with all departments within the company
Be an ambassador for Quality within the company
Maintain professional interactions with all departments and other sites
Ensure facility adherence to cGMP
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