QA/QC Sr. Manager

Quality is critical in the manufacturing of drug products. We are seeking an individual to provide Quality Assurance oversight of the Analytical Quality Control Laboratory and Quality Assurance function for the manufacture of licensed biologic products.

Responsibilities:

-Oversight of the Analytical Quality Control Operation

* Testing is completed appropriately and according to schedule
* Stability schedule is adhered to
* Laboratory is operating in a compliant manner, all data are valid
* Laboratory personnel are properly trained, and have sufficient supplies to maintain performance
* Laboratory assay validation support
* Laboratory is orderly and inspection-ready

-Oversight of Quality Assurance Operation

* All aspects of Quality from receipt of components through release of finished product and maintenance of released inventory
* Quality Risk Management of operations
* Assist or conduct internal and vendor audits
* Assist or conduct batch record reviews and documentation
* Excellent communication skills including writing ability

* Revise SOPs as necessary
* Write, review and/or approve validation and other study documents as appropriate

Requirements:

- A BS with 10 years of pharmaceutical/biologic experience is required, specifically in the areas described above. An advanced degree is preferred.
-Knowledge of cGMPs, FDA guidance documents, ICH documents, industry standards

To find out more about Real please visit www.realstaffing.com