QA Associate

Location
Brisbane, CA, United States
Posted
May 29, 2021
Ref
2097409901
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY

Mammoth Biosciences is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14 and CasPhi, Mammoth Biosciences is advancing disease detection and treatment using its novel CRISPR systems that can deliver on the promise of precision medicine across diagnostics and therapeutics. Furthermore, Mammoth's CRISPR technology platform will enable new solutions in life science research, healthcare, agriculture, biodefense and more.

Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Prize winner Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Decheng, Mayfield, NFX, and 8VC, and leading individual investors including Brook Byers, Tim Cook, Bob Nelsen, and Jeff Huber.

OPPORTUNITY

Mammoth is seeking an experienced QA Associate to play a critical role in executing the Mammoth quality management system (QMS) processes. This individual will work closely with Mammoth employees to ensure SOPs are followed in accordance with FDA 21 CFR 820 and other applicable standards. The QA associate will work closely with subject matter experts to ensure all processes are followed and records meet applicable requirements. The responsibilities include administration and maintenance of quality records for design verification, design validation, equipment maintenance & calibration, and non-conformances in the electronic QMS system. The QA Associate will work with QA leadership and other stakeholders within the company to drive continuous improvement of the quality management system.

KEY RESPONSIBILITIES
    • Assist QA Leadership with the design and implementation of the company's QA function and the QMS
    • Assist with the design, development, approval, and implementation Design Control Quality System's SOPs, forms, and work instructions
    • Review and approve reports, protocols, and documents that will be filed in the Design History Files (DHFs) for the company's products
    • Participate in the company's QMS training efforts
    • Assist in ensuring that the company's QMS is in compliance with all applicable sections of 21 CFR Part 820 and ISO 13485
    • Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures
    • Assist QA and company leadership during internal and external regulatory inspections


REQUIRED QUALIFICATIONS
    • Bachelor's Degree in a scientific field, preferably molecular biology or biochemistry
    • 2 years of QA experience in the medical device or combination products industry
    • Experience and understanding of design, development, verification and validation, design transfer and manufacturing processes and how they are improved and affected by a company's QMS
    • Working knowledge and understanding of regulations 21 CFR 820 and ISO 13485
    • Experience working in a biohazard environment and compliance with policies and standards outlined in the Biosafety Manual


PREFERRED QUALIFICATIONS
    • Ability to manage multiple conflicting priorities
    • Experience with Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance
    • Experience working with an in vitro diagnostic (IVD) product
    • Demonstrated ability to train and coach employees with little quality experience
    • Experience in both large and start-up corporate cultures
    • Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPoint


BENEFITS
    • Company-paid health/vision/dental benefits
    • Unlimited vacation and generous sick time
    • Company-sponsored meals and snacks
    • Wellness, caregiver and ergonomics benefits
    • 401(k) with company matching


It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.