Biopharma QA Specialist in Houston TX

Biopharma QA Specialist in Houston TX


Job ID: 9737301

Houston, TX, US

Scientific

Bachelors Degree

Full Time, Direct Hire

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Houston, TX, US

Experienced (Non-Manager)

Full Time, Direct Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Job details

Kelly Science & Clinical is currently recruiting candidates for a Quality Assurance Specialist for a gene therapy company located in Houston, TX. The overall responsibility of the role will be to ensure quality compliance and oversight for the company’s manufacturing operations.

Responsibilities:
•    Quality approval of cGMP documents including SOPs, batch records, protocols, and specifications 
•    Quality oversight of change controls, non-conformances, OOS, deviations, and related items

  • Ensure investigations are thoroughly investigated and resolved

  • Internal and external compliance auditing including  follow-up of CAPAs

  • QA review of manufacturing and QC related records

  • Review and disposition of raw materials, buffers and other components

•    QA review of initial qualification and validations for facilities, equipment and processes
•    Responsible for maintaining the company’s controlled documents in accordance with quality requirements
•    Work with other departments to ensure high quality work is completed in a timely manner

Job Requirements:
•    Bachelor’s degree in life sciences
•    3-5 years of applicable experience in the Biopharma industry
•    Working knowledge of cGMP requirements for biologics and aseptic manufacturing 
•    Knowledge of cell culture and cell biology
•    Strong organizational, prioritization, problem solving, and communication skills

Ability to follow tasks through to completion and meet deadlines 
•   Ability to make sound decisions based on technical facts and risk assessments

Job Details:
•    Direct Hire
•    Monday – Friday, day shift work schedule
•    Pay rate commensurate upon level of education and applicable experience

9737301

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