Quality Assurance Senior Specialist (Contract)

Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world.
Whether it's the biological diversity of our gene editing systems or the people that help discover them, Metagenomi celebrates the diversity of life. This is achieved through a compassionate culture that acknowledges the dimensions of our diversity. We know that when people feel a sense of inclusion and belonging in the workplace, they have a safe space to bring creativity and innovation to everything they do. We are intentional about building and maintaining a culture where people are valued and respected, there is equity in opportunities, and our respective opinions and differences matter.
We are hiring a Contract Quality Assurance Senior Specialist. Reporting to the Senior Manager, this position will contribute to Metagenomi's Quality Operations by providing quality oversight of GMP manufacturing and support lot release for clinical products. The contract is for approximately six months, with the possibility of conversion to an FTE role. This role will be based in Emeryville, California.
How you'll contribute:

• Assemble and review lot disposition documentation including executed manufacturing batch records and QC test records.
• Perform the raw material, starting material and packaging material disposition for GMP manufacturing use including incoming inspection per approved procedures.
• Responsible for the review and approval of cGMP documentation against Standard Operating Procedures to ensure compliance in Manufacturing processes.
• Create, revise, or review Standard Operating Procedures (SOPs), Material Specifications, Master Batch Records (MBRs) and submit procedural changes as needed to meet local, Global and Regulatory requirements.
• Support the Deviation Management, CAPA and Change Control process.
• Identify areas of non-conformance and compliance risk.
• Support investigations into root causes, implement corrective and preventive actions (CAPAs) to prevent recurrence.
• Develop and deliver quality-related training programs to enhance the skills and knowledge of employees.
• Proactively identify and drive opportunities for continuous improvement and contribute to the implementation of best practices.
• Foster a culture of quality awareness and ensure all staff members are equipped with the necessary tools to contribute to quality improvement efforts.
• Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
• Serve as a Quality partner for internal and external manufacturing providers, including participating or leading Quality sub team meetings, provides quality oversights (QA on Floor) during the operation and CAPA/deviation/change management.
• Collaborate effectively and maintain strong working relationships with a wide variety of stakeholders including Manufacturing, Quality Control, Process Development and Engineering, and others to provide QA oversight, Quality partnership, and to build Quality Culture and a compliance mindset.
• Report quality related performance metrics to Quality Management Review.
• Support the Quality unit with other tasks, as necessary

Must haves:

• BS/MS degree in Biology, Chemical Engineering, Chemistry, or a related field.
• At least five years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience.
• Excellent understanding of GxP requirements with focus on FDA and EMA
• Excellent verbal and written communication skills
• Experience in the areas of Cell and Gene Therapy, Quality Control, Quality Assurance, External Manufacturing Oversight and Supplier Quality Management
• Self-driven and resourceful to deliver results
• Ability to work independently, cross-functionally and within a team
• Ability to lift approximately 45 lbs., stand for an extended period of time and gown into a cleanroom environment.

California Pay Transparency Disclosure:
This position is classified as an non- exempt hourly position under the Federal Labor Standards Act. The anticipated hourly rate for this position will be $60.00. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.
#LI-NG1
What makes Metagenomi a unique place to work?

• We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating disease.
• We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more!
• We offer competitive compensation including a market-benchmarked salary, annual target bonus potential, pre-IPO equity, and a comprehensive benefits plan, including 401(k) with company matching, a retirement safe harbor plan, and other perks.

At Metagenomi, we know that our people drive our success. We are an equal-opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law.
Applicants/Employees have rights under various State and Federal Employment Laws, including without limitation:

• Family & Medical Leave Act
• Equal Employment Opportunity Commission
• Employee Polygraph Protection Act
• California Family Rights Act
• California Fair Employment and Housing Act

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Metagenomi. Agencies and independent recruiters must be approved as a vendor by Metagenomi's Talent Acquisition team. To protect the interests of all parties, Metagenomi will not accept unsolicited resumes, profiles, or biographies. Any unsolicited resumes sent to Metagenomi will be considered referrals and the property of Metagenomi.