Quality Assurance Specialist I

2 weeks ago

Mountain View, California, United States Minaris Regenerative Medicine Full time
Job Overview

Position: Quality Assurance Associate I

At Minaris Regenerative Medicine, we are committed to pioneering advancements in cell and gene therapy. As a prominent global contract development and manufacturing organization, we focus on the potential of regenerative medicine to transform healthcare.

The Quality Assurance Associate is essential in ensuring that all quality assurance processes are executed with precision and efficiency. Working under direct supervision, the associate is responsible for supporting daily operations that are crucial for upholding and enhancing quality systems while adhering to specific client protocols.

Key Responsibilities:

  • Ensure compliance with current Good Manufacturing Practices (cGMP) across all clinical and commercial production activities.
  • Issue batch records and other controlled documents as required.
  • Review manufacturing batch records and associated quality control (QC) data, including bioassays and microbiological testing.
  • Draft, review, and maintain cGMP documentation for Quality System Functions, such as Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Adhere to Standard Operating Procedures and cGMP standards consistently.
  • Maintain comprehensive cGMP documentation, including logbooks and training records.
  • Assist the Manager in prioritizing, scheduling, and managing multiple projects and resources concurrently.
  • Initiate quality events, including deviations, Corrective and Preventive Actions (CAPAs), and Change Controls as necessary.
  • Provide on-the-floor quality assurance support and conduct QA walkthroughs.
  • Perform additional duties as assigned based on business needs.

Qualifications:

  • Bachelor's degree in a relevant scientific discipline.
  • A minimum of one year of experience in a biologics or biotechnology environment.
  • Familiarity with the aseptic manufacturing process of biologics is preferred.
  • Understanding of cGMP regulations.

Competencies:

  • Proficient in Microsoft Office and other relevant software.
  • Detail-oriented with strong organizational skills.
  • Excellent analytical and problem-solving abilities.
  • Effective written and verbal communication skills.
  • Ability to manage multiple tasks and adapt to changing priorities.
  • Capable of working independently as well as collaboratively within a team.

Quality Commitment:

Integrate quality into every aspect of your work by ensuring compliance with all quality standards and regulations.

Working Environment:

This position requires collaboration in a team-oriented setting and may involve working during weekends and holidays as necessary. The role may expose the associate to infectious materials and requires adherence to safety protocols, including the use of personal protective equipment (PPE).

Physical Requirements:

The physical demands of this role include the ability to occasionally lift up to 30 pounds and perform tasks that involve sitting, standing, and using hands for operating office equipment.

Disclaimer:

This job description is intended to convey essential information about the nature and level of work performed. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required for this position. Responsibilities may change as needed.

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