Biopharma QA Specialist in Houston TX
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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