cGMP Specialist (Houston, TX)

| Houston, TX
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Job Summary
At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist 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.

Additional Information: Bachelor's Degree required, Master's Degree preferred in organic chemistry.

PRIMARY JOB RESPONSIBILITIES

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

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. (EF)

QUALITY/SAFETY - 45%
  1. Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet 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. Assists with discrepancy inspections. (EF)

FINANCE - 5%
  1. Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks. (EF)

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. 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.

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
More Information on Houston Methodist
Houston Methodist operates in the Healthtech industry. The company is located in Houston, TX, Baytown, TX, Houston, TX, Houston, TX, Katy, TX, Nassau Bay, TX, Sugar Land, TX and The Woodlands, TX. Houston Methodist was founded in 2022. It has 22000 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Dental Benefits, Vision Benefits, Health Insurance Benefits, Life Insurance and 401(K). To see all 52 open jobs at Houston Methodist, click here.
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