Over the next 10 years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy will dramatically change how we treat cancer and other major illnesses. Biofuels and biomaterials will transform the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology will produce sustainable and ethical food. Benchling’s mission is to accelerate the research that propels us towards this future, and magnify its impact, through modern software.
Every day, scientists and academics around the world use Benchling in their efforts to solve humanity's most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research. Our intuitive, user-friendly platform ensures that science isn't held back by outdated and disconnected tools. With Benchling, all scientists can capitalize on their scientific potential.
Benchling was founded by a team of MIT graduates and has raised funding from Andreessen Horowitz, Benchmark, Menlo Ventures, Thrive Capital, and Y Combinator. Our customers include pharmaceutical giants, leading biotechs, and the world's most renowned research institutes.
As a Quality Assurance Specialist you will perform a wide variety of activities to ensure compliance with applicable GxP requirements. This is a hands-on role helping to establish and support our GxP Compliance Operations across Benchling. You'll work in a fast-paced agile environment to support Benchling's validated product offering.
RESPONSIBILITIES

• Complete GxP reviews and approvals of CSV deliverables including IQ/OQ Protocol and Validation Test Scripts, Validation Plans, Validation Summary Reports, Trace Matrices to ensure adherence to internal policies and procedures, life-science compliance regulations and applicable regulatory guidelines.
• Manage the training compliance matrix. Work with HR to maintain training compliance across Benchling.
• Leads and conducts periodic reviews and generate period review reports.
• Maintain risk assessment for Computer Systems List.
• Conduct Internal Audits and Supplier Audits in support of the Audit Management Program.
• Supports the maintenance and improvement of GxP compliance framework at Benchling. Assist in GxP compliance audits as required.
• Perform root cause analysis and document GxP risk assessment for any logged validation deviations, CAPAs, SCARs and SCRs
• Assist with creating/ updating of procedures and work instructions as required.
• Work with Product Managers to ensure requirements/specifications are defined in a clear, testable format. Ensure requirements are adequately tested following a 21 CFR Part 11 risk based approach
• Ensures GxP compliance across Benchling’s internal SDLC procedures and GxP impacting programs & systems. Supports with related activities as required.

ABOUT YOU

• 2- 5 years of experience in Quality Assurance at a medical, biotech or pharma or equivalent
• B.S. in Science or Engineering
• Have hands-on working knowledge doing GxP risk assessments and compliance reviews with passion for adopting modern quality tools and agile approaches
•  

OUR VALUES

• Empower through information. We explain the “why” behind every decision, unless there are highly sensitive circumstances. We're honest about how we're doing, especially in difficult times. We believe that sharing information builds trust and enables better decision-making.
• Rely on tenacity. Hard work is one of the greatest factors to determine success and is fully under our control. We must make the most of every day by bringing the highest level of determination. Dreaming big is not enough.
• Raise the bar. Pushing ourselves and others to improve will be uncomfortable and at times result in failure. However, it's critical to our success. We're dedicated to creating a place where everyone feels challenged to improve.
• Build a lever. We choose to build tools and infrastructure that will help others make world-changing innovations. There's less glory in it, but in the words of Archimedes, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world."

PERKS AND BENEFITS

• Beautiful, light-filled office in the Financial District of SF
• Monthly health & wellness stipend
• Work with a talented yet humble team
• Meals and snacks covered
• 401k
• Medical, dental, and vision insurance
• Commuter benefits
• Happy hours, company and team wide social events

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.