What are the responsibilities and job description for the cGMP Specialist - Project Management position at Houston Methodist?
The cGMP Specialist Project Specialist drives the successful execution of manufacturing projects within the Office of Translational Production and Quality, serving as the primary liaison between our clients and internal operations. This role encompasses a variety of responsibilities, including developing project plans, tracking and reporting on project resources, deliverables, and milestones, managing budgets, and organizing regular update meetings for project teams. By providing project management oversight, this role contributes to the achievement of strategic goals through strategic input, cross-functional collaboration, and clear visibility on project progress.
At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist position 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 assisting senior team members with 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.
EDUCATION
EXPERIENCE
At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist position 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 assisting senior team members with 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.
FLSA STATUS
Exempt
QUALIFICATIONS
EDUCATION
EXPERIENCE
SKILLS AND ABILITIES
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
SERVICE ESSENTIAL FUNCTIONS
QUALITY/SAFETY ESSENTIAL FUNCTIONS
FINANCE ESSENTIAL FUNCTIONS
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
SUPPLEMENTAL REQUIREMENTS
QUALIFICATIONSExempt
QUALIFICATIONS
EDUCATION
- Bachelor’s degree
- Master’s degree preferred
EXPERIENCE
- Three years of experience in the biotechnology or pharmaceutical industry 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
- Ability to mentor and coach department personnel
- 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.)
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
- 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 SOPs.
- Participates in multi-functional project teams, as necessary.
SERVICE ESSENTIAL FUNCTIONS
- Participates in internal audits and external inspections by Regulatory Agencies.
- Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.
- Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.
- Assists with discrepancy inspections.
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
- 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.
- Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.
SUPPLEMENTAL REQUIREMENTS
- WORK ATTIRE
- Uniform: No
- Scrubs: No
- Business professional: Yes
- Other (department approved): No
- On Call* Yes
- May require travel within the Houston Metropolitan area No
- May require travel outside Houston Metropolitan area 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.
TRAVEL**
**Travel specifications may vary by department**
EDUCATION
- Bachelor’s degree
- Master’s degree preferred
EXPERIENCE
- Three years of experience in the biotechnology or pharmaceutical industry 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