Drug Manufacturing Quality Specialist - Center for Advanced Biomedical Imaging

MISSION STATEMENT

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, and prevention and through education for undergraduate and graduate students, trainees, professionals, employees, and the public.

 
SUMMARY
 

The Drug Manufacturing Quality Specialist will oversee site compliance for the Cyclotron Radiochemistry Facility (CRF). This role is responsible for leading all activities in support of site registration and approvals. This role will also ensure a constant state of readiness regarding inspections and audits through the management of all regulatory inspection logistics and documentation. This individual will foster a strong quality culture and cultivate operational excellence through demonstrated quality leadership. This role will liaise with internal stakeholders.

 
JOB SPECIFIC COMPETENCIES


GMP Documentation

Generates and updates SOPs, logs, and forms describing operating procedures for routine manufacturing, QC and dispensing, equipment daily suitability checks, manufacturing and QC equipment operation, and pharmacy compounding and dispensing.
 
Issues effective dates and serves as system steward for controlled document access and owner of system procedures.

Collects, maintains, and distributes all GMP-controlled documents, both short and long-term, ensuring accessibility during Regulatory Inspections

Identifies and remediates control gaps to efficiently and effectively meet business risk management and compliance requirements.

Daily management of the batch record printing process to ensure operational schedule and customer demands are fully met.

Generates new radiopharmaceutical or process SOPs, reviews, finalizes, and implements same.

Assists with the creation of reports such as:

-         Corrective And Preventive Action (CAPA)

-         Deviations

-         Out-of-Specification (OOS)

-         Change control

-         Product complaint reports

-         Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ) & Validation

-         Staff training records


Maintains documentation on reagents and materials acceptance, inventory control/handling/preparation/disposal.

Performs trending on the manufacturing, QC, and controls data and addresses negative trends.

Assists with staff education and training on SOPs; validation procedures; QC / QA.

Performs/documents investigations for: CAPA, Change control, OOS, Deviations, Product complaints; Manufacturing and QC equipment validation and re-validation and calibration.

Maintains an electronic database for GMP documentation management; CMC documentation management; staff re-training documentation management.

Manages obsolete and revised SOPs notifying staff of changes.

Manages the document printing process to ensure that only most current, approved document versions are available to manufacturing area.

Responsible for document receipt from operational area for short and long-term archival within controlled access facilities.

Maintain GMP Document Management under a state of control at all times to ensure document accessibility and chain of custody.


Regulatory Document Control

Prepares registration documents on behalf of the CRF, such as:

FDA approved manufacturer

-         Texas Board of Pharmacy

-         Nuclear Pharmacy

-         ANDA (Abbreviated New Drug Application) and/or NDA (New Drug Application) package generation & submission (and life cycle management)

·      Other regulatory activities include:

-         CMC section generation (and amendments) and SOPs

-         Communication and/or interaction with the FDA regarding any issue associated with:

o   Clinical manufacturing

o   Generation and submission of response documentation to comments, questions, requests, and/or warnings issued by the FDA regarding clinical manufacturing.

o   Coordination and supervision during FDA inspections

o   Staff training on handling the FDA inspections.

o   Generation and submission of the response documentation to the FDA-issued inspection reports

-         Works with other members of the CRF team to ensure regulatory compliance of the chemistry, manufacturing controls, quality testing controls, quality assurance controls, microbiologic controls, validation and qualification controls, and the manufactured product bioequivalence to the information specified in the ANDA/NDA or an IND (Investigational New Drug) application.

·      Serves as the primary point of contract for regulatory documents when the CRF Charge Radiopharmacist is unavailable to address these affairs.

 
Translational Research Support


Assists radiochemists with introduction of new radiopharmaceutical products into clinical production, which may include:

Converting laboratory procedures to SOPs

-         Meeting with radiochemists to discuss process optimization and large-scale manufacturing considerations.

-         Ensuring cGMPs are incorporated in new procedures.

-         Monitors progress of translation process

-         Process optimization and observing/performing test and validation runs and quality control.

 
Project Management

 
Responsible for the development, supervision, optimization, and evaluation of procedures, documentation, methods and/or databases for current and future projects. These may include, but are not limited to:

Extracting key information from reports and organizing into spreadsheets

Preparing production, QC, and monitoring data charts for trending

Pooling of the production data to generate Annual Production Reports

Preparation and distribution of SOP review lists to qualified personnel

Analytical software data and method management

Labeling changes management

Facility compliance


Other Duties as Assigned

·      Coordinates, plans, and leads special projects as assigned.