Drug Manufacturing Quality Specialist - Center for Advanced Biomedical Imaging

$98,500 - $147,500/Yr

University of Texas M.D. Anderson - Houston, TX

Full-time

Houston, TX

Hospitals

About the position

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.

Responsibilities

• 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 CAPA, Deviations, OOS, Change control, Product complaint reports, 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.
• Prepares registration documents on behalf of the CRF, such as FDA approved manufacturer, Texas Board of Pharmacy, Nuclear Pharmacy, ANDA and/or NDA package generation & submission.
• 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 application.
• Serves as the primary point of contact for regulatory documents when the CRF Charge Radiopharmacist is unavailable to address these affairs.
• Assists radiochemists with introduction of new radiopharmaceutical products into clinical production.
• Responsible for the development, supervision, optimization, and evaluation of procedures, documentation, methods and/or databases for current and future projects.
• Coordinates, plans, and leads special projects as assigned.

Requirements

• Master's degree in a Nursing, Healthcare Administration or related field.
• Ten years of professional experience to include five years in regulatory compliance.

Nice-to-haves

• PharmD
• Three years previous experience communicating with the FDA for drug manufacturing in a cGMP environment.

Benefits

• Full-Time employment
• Onsite presence required
• Minimum Salary: USD 98,500
• Midpoint Salary: USD 123,000
• Maximum Salary: USD 147,500
• Exempt and not eligible for overtime pay