ACM cGMP Specialist I / Production

Houston Methodist•Houston, TX

30d

About The Position

FLSA STATUS Exempt 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 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

Requirements

Bachelor’s degree
Three years of experience in the biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations
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.)

Nice To Haves

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

Responsibilities

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.
Participates in internal audits and external inspections by Regulatory Agencies.
Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
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.
Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks.
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.