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Sr cGMP Specialist-QA/Documentation Specialist at Houston Methodist, HM Texas Medical Center - Research Institute

Sr cGMP Specialist-QA/Documentation Specialist at Houston Methodist in HM Texas Medical Center - Research Institute. Full-time. Est. up to $100k. Apply with swipeandhired.

QA documentation ownership for cyclotron PET radiopharmaceutical cGMP operations
Lifecycle management of SOPs, master batch records, and controlled forms
QA review of executed batch records (paper/electronic) for accuracy, completeness, and GDP compliance
Application of GDP and FDA data integrity principles; resolution of documentation discrepancies
Document control and inspection readiness support, including record organization and retrieval
QC collaboration and documentation/QA cross coverage as needed

At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of equipment and facility cleanliness, proper gowning, correct material labelling, correct operating parameters for equipment and proper execution of protocols in accordance with approved SOPs and the proper guidance of junior level team members. As a senior member of the department, this position will actively contribute to the development of policies and procedures for the delivery of novel products to our patients and customers.

FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION

Bachelor of Arts or Science degree

Master’s degree preferred

EXPERIENCE

Five years of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations

Experience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/ external audits, batch record review and hosting regulatory inspections preferred

SKILLS AND ABILITIES

Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures

Proficiency in spreadsheet, word processing and presentation software

Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented

Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III etc.)

Ability to mentor and coach department personnel

Demonstrates highly effective communication skills and the ability to lead both informal/formal educational sessions to include classroom/seminar instruction in cGMPs and specialized topics related to compliance and best practices

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

Provides work direction of authorized core users working in either production or quality control.

Collaborates with cross-functional teams including research, process development, quality assurance and quality control.

Works with research team members to assist them with transitioning their research processes to compliant cGMP SOP’s and participates in multi-functional project teams as necessary

SERVICE ESSENTIAL FUNCTIONS

Participates in internal audits and external inspections by Regulatory Agencies and reports findings to direct management.

Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

Serves as technical subject matter expert in support of department functions.

Reviews testing documentation from all cross-functional departments

QUALITY/SAFETY ESSENTIAL FUNCTIONS

Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.

Conducts internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.

FINANCE ESSENTIAL FUNCTIONS

Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies.

Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs.

Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.

Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

Identifies opportunities for improvement and leads projects which result in innovative solutions that increase the level of compliance and efficiency of the team.

SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE

Uniform: No

Scrubs: No

Business professional: Yes

Other (department approved): No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.

On Call* Yes

TRAVEL**
**Travel specifications may vary by department**

May require travel within the Houston Metropolitan area No

May require travel outside Houston Metropolitan area No

Work Shift:
1 - Day (United States of America)

Job Category:
Non-clinical

Houston Methodist is one of the nation’s leading health systems and academic medical centers. The health system consists of eight hospitals: Houston Methodist Hospital, its flagship academic hospital in the Texas Medical Center, seven community hospitals and one long-term acute care hospital throughout the Greater Houston metropolitan area. Houston Methodist also includes a research institute; a comprehensive residency program; international patient services; freestanding comprehensive care clinics, emergency care and imaging centers; and outpatient facilities. Come lead with us!
Houston Methodist is an Equal Opportunity Employer.