Top 10 Clinical research specialist Jobs in Houston Tx

cGMP Specialist - Project Management
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Customer service
- Word processing
- English
Sr. Regulatory Compliance Specialist
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Customer service
- 5 years
- English
7d
cGMP Specialist - Clinical Cell Therapy
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Word processing
- English
- Mid-level
3d
Clinical Market Development Specialist (Houston TX)
Medtronic —Houston, TX
- $95,000 a year
- Full-time
- Remote
- Nursing
- Public speaking
- Analysis skills
- Health savings account
- Employee stock purchase plan
Clinical Sales Specialist, Structural Heart, TEER (Houston, TX)
Abbott Laboratories —Houston, TX
- $78,000 - $156,000 a year
- Full-time
- Up to 50% travel
- Bachelor of Science
- Mid-level
- Health insurance
- Tuition reimbursement
Communication Specialist for the Center for Clinical and Translational Sciences
UTHealth Houston —Houston, TX
- Full-time
- Mid-level
- Office
- 3 years
- Health insurance
- Employee discount
14d
Clinical Sales Specialist, Electrophysiology - LAAO (Houston, TX)
Abbott Laboratories —Houston, TX
- $68,000 - $136,000 a year
- Full-time
- 6 years
- Up to 50% travel
- Bachelor of Science
- Health insurance
- Tuition reimbursement
Clinical Research Specialist (Neurology Department)
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Hospital
- Writing skills
- English
10d
Data Integrity Specialist
Memorial Hermann Health System —Houston, TX
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
11h
NICU Clinical Pharmacist Specialist
Memorial Hermann Health System —Houston, TX
- 8 hour shift
- Surgery
- Customer service
- Bachelor of Science

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cGMP Specialist - Project Management

Houston Methodist Academic Institute -
Houston, TX

Apply Now

Job Details

Full-time

Qualifications

Biotechnology
English
Manufacturing facility experience
Bachelor's degree
Pharmaceutical company experience
Pharmaceutical manufacturing facility experience

Full Job Description

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.

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

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.

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

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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.

Apply Now

Refine Your Search

clinical research specialist jobs in houston tx

cGMP Specialist - Project Management

Sr. Regulatory Compliance Specialist

cGMP Specialist - Clinical Cell Therapy

Clinical Market Development Specialist (Houston TX)

Clinical Sales Specialist, Structural Heart, TEER (Houston, TX)

Communication Specialist for the Center for Clinical and Translational Sciences

Clinical Sales Specialist, Electrophysiology - LAAO (Houston, TX)

Clinical Research Specialist (Neurology Department)

Data Integrity Specialist

NICU Clinical Pharmacist Specialist

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