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cGMP Specialist - Quality Control Flow Cytometrist job in Houston at Houston Methodist

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cGMP Specialist - Quality Control Flow Cytometrist at Houston Methodist

cGMP Specialist - Quality Control Flow Cytometrist

Houston Methodist Houston, TX Full-Time
JOB SUMMARY

At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist Quality Control (QC) Flow Cytometrist position is responsible for providing technical and scientific support to researchers with flow cytometry, performing routine cleaning and maintenance of instrumentation, maintaining adequate level of lab supplies to assure timely achievement of lab activities, and maintaining accurate and timely records to include notebooks, forms, etc., as needed, by the research project. The position will be able to independently operate flow cytometers (CliniMACS Quant) and has experience in experimental design, instrument setup, quality control, sample acquisition, data analysis This position will also be responsible for execution of procedures and QC tests such as endotoxin, mycoplasma and sterility tests, as needed, to support QC operations. As a member of the Office of Translational Production & Quality, the cGMP Specialist QC Flow Cytometrist position offers the ability to actively participate in the development of policies and procedures for the delivery of novel products to our patients and customers and pursue continuing education opportunities.

Requirements:

PRIMARY JOB RESPONSIBILITIES

Job responsibilities labeled EF capture those duties that are essential functions of the job.

PEOPLE - 15%

* Collaborates with cross functional teams including research, process development, quality assurance and quality control. (EF)
* Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs. (EF)
* Participates in multi-functional project teams, as necessary.

SERVICE - 20%

* Participates in internal audits and external inspections by Regulatory Agencies. (EF)
* Responds to calls/alarms off hours and weekends for facility systems and equipment failures. (EF)

QUALITY/SAFETY - 45%

* Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements. (EF)
* Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures. (EF)
* Assists with discrepancy inspections. (EF)

FINANCE - 5%

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

GROWTH/INNOVATION - 15%

* 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. (EF)
* Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development. (EF)

This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications:

EDUCATION REQUIREMENTS

o Bachelor's degree

o Master's degree preferred

EXPERIENCE REQUIREMENTS

o Three years of experience in the biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations

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

CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

o None

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

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

o 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

o 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

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

o Proficiency in spreadsheet, word processing and presentation software

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

o Ability to mentor and coach department personnel

o 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.)

SUPPLEMENTAL REQUIREMENTS

Work Attire Yes/No

Uniform No

Scrubs No

Business professional Yes

Other (dept approved) No

On-Call* Yes, on a limited basis (for Exempt jobs only)

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

Travel

May require travel within No

Houston Metropolitan area

May require travel outside No

of Houston Metropolitan area

Travel specifications may vary by department.

Please note any other special considerations to this job: _________________________

Company Profile:

Houston Methodist Academic Institute was formed to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The Research Institute was created in 2004 to provide the infrastructure and support for these endeavors and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000-square-foot building dedicated to research and clinical trials, the Academic Institute houses over 2,110 credentialed researchers conducting 1,387 ongoing clinical protocols.

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