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Job description

Applied StemCell is a fast-growing biotechnology company headquartered in the San Francisco Bay area, California. Our goal is to advance gene-editing and stem cell innovation for biomedical research and therapy.

We are looking for an enthusiastic QA associates ensuring the quality and compliance of products or processes within a company

Qualification

· BS degree in biology or a related field.

· Knowledge of Cell Therapy

· Regulatory Compliance: Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulations set forth by regulatory authorities like the Food and Drug Administration (FDA) or other relevant agencies will be highly desirable

· Quality Management Systems: Familiarity with quality management systems (QMS) and their implementation in the context of cell therapy is highly desirable. This includes experience with documentation practices, change control, deviation management, Corrective and Preventive Actions (CAPA), and risk management.

· Validation and Qualification: Experience and understanding of validation and qualification processes for cell therapy manufacturing equipment, processes, and analytical methods will be highly desirable. This includes equipment qualification, process validation, and analytical method validation.

Job Duties

· Developing and implementing quality assurance processes: QA Associates are responsible for establishing and implementing quality assurance procedures and protocols specific to cell therapy. They ensure compliance with regulatory requirements, industry standards, and company policies.

· Conducting quality inspections and tests: QA Associates perform inspections and tests throughout the cell therapy manufacturing process to ensure product quality and compliance. This includes reviewing documentation, conducting visual inspections, performing in-process testing, and analyzing data.

· Documenting and reporting: QA Associates document their findings, test results, and any deviations or non-conformances identified during inspections. They generate reports and maintain accurate records of quality control activities.

· Participating in process improvement: QA Associates collaborate with cross-functional teams to identify areas for process improvement and implement corrective actions. They provide feedback on manufacturing processes, propose solutions to enhance product quality and efficiency, and support continuous improvement efforts.

· Supporting validation and qualification activities: QA Associates contribute to the validation and qualification processes for cell therapy manufacturing equipment, processes, and analytical methods. They assist in executing validation protocols, documenting results, and ensuring compliance with validation requirements.

· Conducting internal audits: QA Associates perform internal audits to assess compliance with quality standards, regulatory requirements, and company policies. They identify potential risks and areas for improvement, and work with teams to address any non-compliances.

· Assisting in regulatory inspections: QA Associates may participate in regulatory inspections and audits by providing necessary documentation, supporting compliance assessments, and addressing any findings or observations.

· Training and education: QA Associates may contribute to training programs and provide guidance to personnel involved in cell therapy manufacturing. They ensure that employees are aware of and follow quality assurance procedures and standards.

· Keeping up with industry trends and regulations: QA Associates stay updated on evolving regulatory requirements, industry guidelines, and advancements in cell therapy to ensure that quality assurance practices remain current and effective.

Benefit Conditions:

• Only full-time employees eligible

Work Remotely

• No

Job Type: Full-time

Pay: From $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Education:

• Associate (Preferred)

Experience:

• Laboratory Experience: 1 year (Preferred)
• Biotechnology: 1 year (Preferred)

Work Location: In person

Apply Here

About Applied StemCell

CEO: Ruby Tsai
Revenue: $5 to $25 million (USD)
Size: 1 to 50 Employees
Type: Company - Private
Website: www.appliedstemcell.com
Year Founded: 2007