Quality Assurance Associate
Gameto
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Vantaggi offerti da questo lavoro
Descrizione del lavoro
Competenze
- Minimum 1 year of quality assurance experience, preferably in a regulated environment.
- Understanding of GLP regulations and quality systems standards.
- Experience with operational quality roles in a GLP setting is required.
Mansioni
- Ensure that laboratory operations comply with GLP regulations.
- Assist in the implementation of the Quality Management System.
- Participate in internal audits for compliance.
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
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 - $110,000.00/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 LinkedIn 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 at the forefront of cell and molecular biology. You’ll join a collaborative environment that values precision, purpose, and progress.
Gameto is a pioneering biotechnology company in women’s health, co-founded by Dina Radenkovic, a physician-turned-entrepreneur, and Martin Varsavsky, a leader in fertility innovation and founder of the Prelude Network.
With our groundbreaking cell engineering platform—developed through a collaboration with Harvard University’s Wyss Institute and Professor George Church’s lab at Harvard Medical School—we aim to create treatments for menopause and infertility affecting the female reproductive system. Our scientific approach surpasses traditional therapeutic modalities and sets a new gold standard for research and development in the field.
Backed by $73 million raised in Series A and B funding from Insight Partners, Future Ventures, RA Capital, Two Sigma Ventures, Lux Capital, and others as well as $10 million from ARPA-H, Gameto is committed to transforming women’s healthcare through bold innovation.
Read about us in: MIT Technology Review, The New Yorker, The Boston Globe, and Stat News.
At Gameto, we value kindness, collaboration, authenticity, and diversity. We are an equal opportunity employer and are committed to creating an inclusive environment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- Seniority level: Associate
- Employment type: Full-time
- Job function: Quality Assurance
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