Quality Assurance Specialist Jobs

Role Summary:

The Quality Assurance Specialist is accountable to the Sr. Director of Quality and will be responsible for managing the document control and training systems. Responsibilities also include reviewing drug product, labeling and secondary packaging documentation required for product disposition, and supporting activities to ensure adherence to internal procedures and applicable regulatory requirements.

Responsibilities will include:

• Identify and support process optimizations activities.
• Communicatedocumentation discrepancies and facilitate discussions to ensure a timely resolution.
• Ensure Quality Assurance maintains an effective and compliant document control and training system.
• Create and revise SOPs to ensure procedures reflect current practices and are compliant to applicable GxP regulations.
• Perform QA reviews of QC and stability study protocols/ reports.
• Assist with additional activities, as needed.
• Review and approve drug product, labeling and secondary packaging batch records and associated documentation.
• Review specifications and CoAs.

Qualifications:

• Strong knowledge of cGMP requirements.
• Experience reviewing GMP batch records is preferred.
• Experience working in an EDMS (Electronic Document Management System), such as SmartSolve.
• Proficient in Microsoft Outlook, Word, Excel, PowerPoint and SharePoint.
• Ability to manage deadlines and prioritize effectively, while maintaining flexibility.
• Familiarity with stability studies and QC / analytical methods is preferred.
• Ability to work independently and take initiative.
• Excellent written and verbal communication skills.
• Bachelor’s degree in a Life Sciences or Chemistry discipline and at least 5 years of relevant GMP QA experience in the pharmaceutical/ biotech industry.
• Experience working with CMO’s is preferred.