Supervisor, QA Document Control

Abraxis BioScience, LLC is a fully integrated biotechnology company dedicated to delivering progressive therapeutics and core technologies that offer patients and medical professionals safer and more effective treatments for cancer and other critical illnesses. The Abraxis portfolio includes the world's first and only protein-based nanoparticle chemotherapeutic compound (ABRAXANE) which is based on its proprietary tumor targeting system known as the nab Technology platform. From the discovery and research phase to development and commercialization, Abraxis BioScience is committed to rapidly enriching the company's pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of the patients who need them.

POSITION SUMMARY

The Supervisor QA Document Control carries out supervisory responsibilities in accordance with the organization’s policies, procedures, state, federal, and local laws.  Under general supervision, coordinates and directs activities of the QA Document Control group.  The Supervisor assures individual compliance with the DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and Abraxis policies and procedures.

ESSENTIAL FUNCTIONS

*Oversees, supervises, coordinates and prioritizes the daily activities of the QA Document Control group.

*Performs system administrator functions for QA Document Control databases.

*Ensures timely processing of controlled document change requests, notifies site personnel of revised document training requirements, maintains documents, and distributes controlled documents per QA Document Control procedures.

*Oversees site Change Control procedure and tracks changes for SOP’s, Policies, Equipment, Labeling, Master Batch Production Records, Material Control Specifications, Product Specifications and Test Methods.  Approves Change Requests for implementation.

*Oversees the creation and revision of labeling components, specifications and graphics according to applicable SOPs and cGMPs.

*Responsible for the timely issuance of Batch Folders prior to product manufacture and for file maintenance after manufacture.

*Conducts site new Employee (NEO) training for QA Document Control procedures contained in CORE Curriculum.

*Responsible for interviewing, hiring and writing of performance reviews of personnel to assure the area of responsibility is adequately staffed. Provides coaching and mentoring to subordinates in the areas of training, disciplinary action, problem solving, and professional growth.

*Responsible for attending meetings and representing the department in those meetings that may have an affect upon the operation of the area of responsibility.

*Conducts Deviation Investigations in area of responsibility. Assists other QA groups with Deviation Investigation QA Summaries and closures.

*Oversees processing and input into the Learning Management System for documented training events and curricula assignment changes. Ensures completed training related documents are filed appropriately per written procedures.

*Ensures that employees make appropriate progress on their training curriculum.  Determines work assignments according to the individual employee’s training and qualification status.  Ensures that training documentation is accurate and timely.

*Oversees site Documentation Center for record retention.  Ensures critical documents are processed into the Documentation Center in a timely manner, maintained securely, and available for viewing, copying and removal for regulatory inspection per standard operating procedures.

EDUCATION/EXPERIENCE REQUIREMENTS

*Require a Bachelors degree from an accredited college or university with a minimum of 8 years related experience in a regulated industry, preferably in a pharmaceutical environment.

*An equivalent combination of education, experience and training may substitute.