Quality Assurance Associate

This range is provided by Gameto. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$80,000.00/yr - $/yr

Annual Bonus

Gameto is seeking a highly organized and detail-driven Quality Assurance Associate to support compliance oversight and quality system implementation across our pioneering R&D and manufacturing teams. This is a vital quality-focused role, ideal for someone who thrives in a fast-paced biotech environment and is passionate about advancing cell therapy innovation in women’s health.

As a Quality Assurance Associate
, you’ll help ensure our operations remain efficient, safe, and compliant with GLP standards
, while supporting a culture of continuous improvement. If you’re excited about science, systems thinking, and driving quality in a dynamic research setting, we’d love to hear from you.

The Quality Assurance Associate will be responsible for supporting the day-to-day execution and maintenance of our Quality Management System (QMS), including document control
, internal auditing
, and GLP compliance
. You will work cross-functionally with our scientific and operational teams to uphold quality across research activities, preclinical programs, and early-stage manufacturing efforts.

We’re looking for someone who is meticulous, solutions-oriented, and eager to grow with us as we scale our platform. This is a unique opportunity to help shape a world-class quality function from the ground up in a mission-driven company improving reproductive health.

• Ensure that laboratory operations and studies comply with applicable GLP regulations.
• Support QA review of study protocols, SOPs, raw data, and final reports for GLP adherence.
• Track and monitor training requirements for GLP personnel.

• Assist in the implementation, maintenance, and continuous improvement of the QMS.
• Manage and archive quality documents such as SOPs, policies, and forms.
• Maintain controlled documentation systems and support electronic document management.

• Participate in internal audits to assess GLP compliance and QMS effectiveness.
• Assist with scheduling, conducting, and documenting internal audits and external vendor audits.
• Follow up on audit findings to ensure proper implementation of corrective actions.

• Work closely with QA, R&D, and Laboratory Operations teams to ensure quality expectations are met.
• Support quality training efforts and foster a culture of continuous improvement.

• Bachelor’s degree in Life Sciences, Biology, Chemistry, or a related field.
• Minimum 1 year of quality assurance experience
  , preferably in a regulated laboratory or biotech environment.
• Understanding of GLP regulations and quality systems standards (e.g., ISO, ICH). Experience with operational quality roles in a GLP setting is required.
• Strong organizational and analytical skills with attention to detail.
• Effective verbal and written communication skills.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook).

• Experience in biologics
  , cell therapy
  , or toxicology research environments.
• Prior involvement with laboratory-based or nonclinical research QA oversight.
• Familiarity with electronic QMS platforms and audit management tools.

If you’re excited to contribute to a mission-driven company and enable scientific excellence through operational leadership, we encourage you to apply today!

Please apply on Linked In and submit the following materials in a single PDF:

• A cover letter that describes your experience in lab operations and management
• Highlights what excites you about joining Gameto
• Shares your anticipated start date and any other relevant information
• Includes anything else you’d like to share with us to help us get to know you better
• CV/resume

At Gameto, you’ll be part of a team building transformative therapies to support women’s health. As a Quality Assurance Associate your work will be instrumental in enabling scientific breakthroughs and supporting teams working…