Drug Manufacturing Quality Specialist

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.

The ideal candidate will have prior experience with drug manufacturing quality assurance; experience with regulatory bodies; experience with industry & contracting.

SUMMARY

The primary purpose of the Drug Manufacturing Quality Specialist is to successfully coordinate the documentation aspects of Good Manufacturing Practices (GMP) via the development and management of Standard Operating Procedures (SOPs) for the Cyclotron Radiochemistry Facility.

CORE VALUES

Caring: By our words and actions we demonstrate caring toward everyone.

• We are sensitive to the concerns of our patients, their loved ones and our colleagues.
• We are respectful and courteous to each other and practice cultural humility.
• We promote and reward teamwork and inclusion.

Integrity: We work together with professionalism to merit the trust of our colleagues and those we serve in all that we do.

• We hold ourselves, and each other, accountable for our work - decisions and data - and for practicing our values and ethics.
• We advocate for diversity and equity for our workforce, for those we serve and for our community.
• We communicate frequently, honestly, openly and responsibly.

Discovery: We embrace creativity and seek new knowledge from diverse perspectives.

• We encourage continuous learning, seeking out information and new ideas.
• We team with each other to identify and resolve problems.
• We seek personal growth and enable others to do so.

Safety: We provide a safe environment - physically and psychologically - for our patients, for our colleagues and for our community.

• We create a sense of security and empowerment and are committed to keeping one another free from harm.
• We embrace a framework and best practices for the highest quality of care and service.
• We inspire trust by modeling excellence in our work and acceptance of each person's contributions.

Stewardship: We protect and preserve our institutional reputation and the precious resources - people, time, financial and environmental - entrusted to us.

• We prioritize the health and well-being of each other.
• We act responsibly to safeguard the institution's finances.

• We ensure the proper care and use of time, data, materials, equipment and property afforded to us.identify and solve problems; Seeks personal growth and enables others to do so.

JOB SPECIFIC COMPETENCIES

1. 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
•Manages the paper 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 time to ensure document accessibility and chain of custody

2. 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) & SOPs
-Communication and/or interaction with the FDA regarding any issue associated with:
§Clinical manufacturing
§Generation and submission of response documentation to comments, questions, requests, and/or warnings issued by the FDA regarding clinical manufacturing
§Coordination and supervision during the FDA inspections
§Staff training on handling the FDA inspections
§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 contact for regulatory documents when the CRF Charge Radiopharmacist is unavailable address these affairs

3. 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

4. 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
-Production schedule
-Facility operation
-Staffing
-CAPA

5. Other Duties as Assigned: •Coordinates, plans, and leads special projects as assigned.

Other duties as assigned

COMPETENCIES

Develop Oneself - Pursue learning and self-development; actively seek feedback; transfer learning into next steps; set high standards of performance; drive for results and achievement.

Self-Adaptability - Work in situations involving uncertainty, shifting priorities, and rapid change; deal constructively with mistakes and setbacks; demonstrate flexibility.

Technical/Functional Expertise - Demonstrate technical proficiency required to do the job; possess up-to-date knowledge in the profession; provide technical expertise to others.

With Inclusion, you understand that your ideas and contributions are valued. You promote the same for others. You address your own biases while promoting diversity and equity. (Competencies: Cultural Humility, Cultural Awareness, Cultural Intelligence)

With Drive, you see that you can serve as a leader whether you have a formal leadership role or not. You tackle problems, move past setbacks and hardships, and don't lose sight of your goals. (Competencies: Self-Confidence, Analytical Thinking, Innovative Thinking, Technical Expertise)

You demonstrate Professionalism by setting the example for others and consistently modeling MD Anderson's values and service standards. You communicate effectively in a variety of ways. (Competencies: Inspire Trust, Oral Communication, Written Communication)

Through Emotional Intelligence, you maintain awareness of your own emotions and the emotions of those around you. Use nonverbal cues and feelings to engage others in an inclusive and responsive way. (Competencies: Active Listening, Teaming, Self-Reflection)

Having Coachability means you are engaged in relentless learning. You constantly ask questions and stay curious. You understand that the organization constantly evolves, and you should as well. (Competencies: Develop Oneself, Adaptability)

You must first hold yourself accountable through Professionalism. When you move to Accountability for others, you must communicate in a way that compels them into action and drives them to achieve goals. (Competencies: Strategic Thinking, Provide Direction, Influence, Interpersonal Communication)

When you demonstrate Knowledge Sharing, you create a culture of learning within your team. You instill in others a drive to learn and develop. (Competencies: Knowledge Transfer, Business Acumen)

When you take on Capacity Building, you continuously motivate the talent within your team; you value the strength that diversity brings and provide ongoing growth and development to every team member. (Competencies: Coach and Develop, Change Leadership, Inclusive Leadership)

Required education: Master's degree in a Nursing, Healthcare Administration or related field.

Required experience: Ten years of professional experience to include five years of human subject research in regulatory compliance.

This position is hybrid with some required onsite time; required onsite training/onboarding.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html