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Senior Specialist, Quality Systems & Document Control (Contract)

metagenomi · 30+ days ago
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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.

The Contract Senior Specialist, Quality Systems & Document Control will be responsible for ensuring compliance with established quality standards across all applications, systems, and projects. This role involves administering GxP documentation workflows, safeguarding quality records, and managing their issuance, retention, and archival.  This position is located in Emeryville, California. 

Key Responsibilities:

  • Collaborate with various stakeholders to create and format documents and templates as they progress through the eQMS.
  • Administer eQMS system workflows, performing compliance reviews of draft documentation to ensure adherence to quality standards.
  • Execute document control procedures, including the creation, routing, review, approval, distribution, periodic review, and archiving of new and revised controlled documents.
  • Serve as a Subject Matter Expert (SME) by providing compliance training on Document Control and other related programs within your scope of responsibility.
  • Issue, track, reconcile, and archive paper records, such as controlled forms, batch records, and laboratory notebooks.
  • Assist in compiling monthly KPI/metrics, performing trend analysis on the Document Control and Training systems to ensure ongoing compliance.

What you bring: 

  • An undergraduate degree in the life sciences
  • At least 5 years of experience in Quality Systems and Document Control, with a strong focus on GxP documentation and eQMS administration.
  • Experience with electronic Document Management Systems
  • Advanced proficiency in Microsoft Word, and basic skills in Excel and Adobe Acrobat Professional.
  • Experience in training personnel on Document Control and Quality Assurance concepts.
  • Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
  • Strong communication, problem-solving, and prioritization skills.

California Pay Transparency Disclosure:

Under the Federal Labor Standards Act (FLSA) this position is classified as non-exempt.  The anticipated hourly rate for this position will be $52.00 to $62.00.  Please note the final hourly rate will be determined at the Company's sole discretion and may vary based on a variety of factors, including skill level, years and depth of relevant experience, education, and location. 

 

#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 diseases.
  • 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, equity, comprehensive benefits plan, 401(k) with company matching, 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:

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.

Metagenomi Applicant Privacy Notice

Purpose of Data Collection

At Metagenomi, we are committed to protecting the privacy of our job applicants. The personal information you provide during the application process is collected to evaluate your suitability for employment with Metagenomi. This notice outlines how we collect, use, store, and protect your personal data.

Types of Data Collected

We may collect and process the following types of personal information:

  • Contact Information: Name, address, phone number, email address.
  • Employment History: Previous employers, job titles, dates of employment.
  • Education: Educational institutions attended, degrees earned.
  • References: Names and contact information of your references.
  • Other Relevant Information: Any additional information you choose to provide in your application or resume.

Data Usage

The personal information we collect is used for the following purposes:

  • To process and evaluate your job application.
  • To communicate with you about your application status.
  • To conduct background checks and verify your information.
  • To comply with legal and regulatory requirements.

Data Sharing

We may share your personal information with:

  • Internal Departments: Relevant Metagenomi departments involved in the recruitment process.
  • Third-Party Service Providers: Background check companies, recruitment agencies, and other service providers who assist us in the recruitment process. These providers are obligated  to protect your information and use it only for the purposes specified by Metagenomi.
  • Legal Authorities: As required by law or in response to legal processes.

Data Storage and Security

Your personal information is stored securely in our databases and systems. We use appropriate technical and organizational measures to protect your data against unauthorized access, loss, or misuse. Your data will be retained for as long as necessary to fulfill the purposes for which it was collected or as required by law.

Applicant Rights

You have the following rights regarding your personal information:

  • Access: You can request access to the personal information we hold about you.
  • Correction: You can request corrections to any inaccurate or incomplete information.
  • Deletion: You can request the deletion of your personal information, subject to legal and regulatory obligations.
  • Objection: You can object to the processing of your personal information in certain circumstances.

Metagenomi complies with applicable data protection laws, including the California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR). We are committed to protecting your privacy and ensuring that your personal information is handled in accordance with the highest standards.

By submitting your application, you acknowledge that you have read and understood this Applicant Privacy Notice and consent to the processing of your personal data as described above.

 

Last updated on Aug 19, 2024

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