Quality Assurance Manager

4 weeks ago

Houston, United States Astrix Inc Full time

QA Manager opening at a biotechnology company focused on spearheading breakthroughs in regenerative medicine using adult, autologous Mesenchymal Stem Cells.

QA Manager

Schedule: M-F Onsite, 8-5pm, (flexible to 8:30-530 or 9-6 if needed)

Pay: $80-95k

2 direct reports: QA associates

  • Provide comprehensive quality oversight and guidance throughout the end-to-end manufacturing process of cell therapy products for individual use or for clinical trials.Ensure that our Mesenchymal Stem cell products meet the highest standards of quality and reliability.
  • Oversee the life cycle from starting materials until Finished Goods manufacturing.
  • Ensure compliance with regulations, contributing to the development of the quality management system, and providing innovative quality input and support to company.
  • Be an expert in quality management system, ensuring activities conform with requirements.
  • Be a subject matter expert on investigations, deviations, root cause analysis tools, CAPAs, change control, and complaint investigations.
  • Support and participate in compliance audits, OSHA inspections, and interactions with regulatory agencies.
  • Identify compliance gaps, quality issues/discrepancies, and effectively and proactively resolve them in a flexible and constructive manner.
  • Corrective and preventative actions (CAPA) - Implementation and Evaluating the adequacy and effectiveness of corrective and preventive action plans
  • Deviation & out of specification (OOS) reporting
  • Complaint and recall handling
  • Calibration and maintenance coordination
  • Qualification & validation coordination
  • Internal and external audits including vendor /supplier qualification.
  • Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites.

Education/ Experience:

Possess a Bachelors degree in life sciences AND a minimum of 7 years of relevant experience in the biotechnology, pharmaceutical or biological sciences industry OR Masters degree with 4 years of experience.

Have at least 2 years of demonstrated experience in Quality Assurance operations, preferably in a management role. (1-2 years in a lead or supervisory role- does not have to be within QA but preferred).

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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