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ACM cGMP Specialist I
Job Ref # 13513
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Location:
Houston Methodist Academic Institute
6670 Bertner Ave
Houston, TX 77030

Category: Academic Institute

Job Type: Full-Time

Posted Date: Aug. 9, 2021

JOB SUMMARY
At Houston Methodist, this position will be accountable for adherence to 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.
As a member of the Office of Translational Production & Quality, this position will actively participate in the development of policies and procedures for the delivery of novel products to our patients and customers.

Requirements:

PRIMARY JOB RESPONSIBILITIES

PEOPLE - 15 %

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

SERVICE - 20 %
  1. Participates in internal audits and external inspections by Regulatory Agencies. (EF)
  2. Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
  3. Demonstrates the components of the ICARE values statement.

QUALITY/SAFETY - 45 %
  1. Ensures development, pre-clinical and clinical product supply is executed effectively against changing demand schedule and meets quality requirements. (EF)
  2. Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures. (EF)
  3. Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards.
  4. Completes all hospital required and job-related in-services and applies the information as needed.

FINANCE - 5 %
  1. Works in an efficient and cost-conscious manner.

GROWTH/INNOVATION - 15 %
  1. 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)
  2. Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.

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

  • BA/BS with 3 years experience or Masters with 1 year experience

EXPERIENCE REQUIREMENTS
  • 3 years experience in cGMP quality assurance or manufacturing with a BA/BS or 1 year experience in cGMP quality assurance or manufacturing with a Masters degree

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

  • None

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

  • Biotechnology, pharmaceutical industry experience with exposure 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.

SUPPLEMENTAL REQUIREMENTS


Work AttireYes/No
Uniform No
ScrubsNo
Business professionalYes
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: N/A



Company Profile:

A cornerstone of Houston Methodist's strategic vision as a source for leading care, Houston Methodist Academic Institute conducts ground breaking translational and clinical research to provide the best care to patients in our community and around the world. At Houston Methodist, fostering innovations with the potential for clinical application is at the very heart of what we do. Our interdisciplinary teams of clinicians and researchers are committed to streamlining the process of translating discoveries into treatments and cures for our patients.

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