Benchling
QA Specialist
Benchling, San Francisco, California, United States, 94199
Biotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new speed of science requires better technology.Benchling’s mission is to unlock the power of biotechnology. The world’s most innovative biotech companies use Benchling’s R&D Cloud to power the development of breakthrough products and accelerate time to milestone and market.Come help us bring modern software to modern science.Role Overview
This position will play a key role in Benchling’s GxP Compliance team. This is a hands-on, individual contributor role and will have responsibilities for day-to-day management of the Audits & Inspections Program. You'll work in a fast-paced agile environment supporting Benchling's expansion into development and manufacturing domains.Responsibilities
Plan and complete internal audits on key process areas in the scope of Benchling’s QMS.Manage customer audits and assessments including responses to vendor quality questionnaires.Document and maintain a comprehensive supplier management program that includes assessments & audits of our GxP relevant software and service vendors and partners.Maintain the annual audit schedule and coordinate with respective functional areas managers on planning and completing audits.Plan and lead pre-audit meetings with internal and external partners. Lead debrief meetings to communicate audit outcomes; Prepare audit reports and responses and follow up on related corrective actions required.Maintain an up-to-date computer systems inventory in collaboration with Benchling’s IT and Security teams. Complete GxP System Impact Assessments as needed.Support organizational change activities for product and internal GxP systems as needed. Assist with creating/ updating procedures and work instructions as the need arises.Follow up on audit related CAPAs, SCARs and communicate results back to suppliers and/or customers.Conduct QA reviews on quality & compliance guidelines that are implemented and followed across Benchling’s internal SDLC and GxP impacting business systems.Support with related activities as needed to ensure continuous compliance.Qualifications
Bachelor's degree in Science, Engineering or Regulatory Compliance.3-5 years of experience in Life Sciences supporting Quality Assurance, Regulatory Operations or Audits & Inspections.Have working knowledge of GxP regulatory requirements.Have strong verbal and written communication skills.Able to work independently and be flexible to changing priorities.Able to handle multiple projects in a fast-paced environment.Able to collaborate effectively in a multifaceted, cross-functional environment.Meticulous; must be detailed and organized in the handling of documents with solid organizational skills and ability to prioritize multiple tasks.Have hands-on working knowledge doing GxP risk assessments and compliance reviews with passion for embracing modern quality tools and agile approaches.SALARY RANGE
Benchling takes a market-based approach to pay. The candidate's starting pay will be determined based on job-related skills, experience, qualifications, interview performance, and work location. For this role the base salary range is:ZONE 1: $118,320 to $160,080ZONE 2: $110,075 to $148,925ZONE 3: $106,505 to $144,095To help you determine which zone applies to your location, please see this resource. If you have questions regarding a specific location's zone designation, please contact a recruiter for additional information.Total Compensation
Total Compensation includes the following:Competitive salary and equity.100% premiums covered for health, dental, and vision for employees.Fertility healthcare and family-forming benefits.Four months of fully paid parental leave.401(k) + Employer Match.Commuter benefits.Home office stipend.Mental health benefits + Wellness stipend.Learning and development stipend.Generous PTO.Company-wide Summer & Winter holiday shutdown.Sabbaticals for 5-year and 10-year anniversaries.Diversity and Inclusion
Benchling welcomes everyone. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. We are an equal opportunity employer. That means we don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.For applicants for U.S.-based roles only: All new hires in the United States are required to be fully vaccinated against COVID-19 and to provide proof of vaccination prior to their first day of employment. If you are unable to be vaccinated for medical or religious reasons, we will explore potential reasonable accommodations; however, Benchling may not be able to grant such accommodations in all cases if doing so would cause undue hardship.
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This position will play a key role in Benchling’s GxP Compliance team. This is a hands-on, individual contributor role and will have responsibilities for day-to-day management of the Audits & Inspections Program. You'll work in a fast-paced agile environment supporting Benchling's expansion into development and manufacturing domains.Responsibilities
Plan and complete internal audits on key process areas in the scope of Benchling’s QMS.Manage customer audits and assessments including responses to vendor quality questionnaires.Document and maintain a comprehensive supplier management program that includes assessments & audits of our GxP relevant software and service vendors and partners.Maintain the annual audit schedule and coordinate with respective functional areas managers on planning and completing audits.Plan and lead pre-audit meetings with internal and external partners. Lead debrief meetings to communicate audit outcomes; Prepare audit reports and responses and follow up on related corrective actions required.Maintain an up-to-date computer systems inventory in collaboration with Benchling’s IT and Security teams. Complete GxP System Impact Assessments as needed.Support organizational change activities for product and internal GxP systems as needed. Assist with creating/ updating procedures and work instructions as the need arises.Follow up on audit related CAPAs, SCARs and communicate results back to suppliers and/or customers.Conduct QA reviews on quality & compliance guidelines that are implemented and followed across Benchling’s internal SDLC and GxP impacting business systems.Support with related activities as needed to ensure continuous compliance.Qualifications
Bachelor's degree in Science, Engineering or Regulatory Compliance.3-5 years of experience in Life Sciences supporting Quality Assurance, Regulatory Operations or Audits & Inspections.Have working knowledge of GxP regulatory requirements.Have strong verbal and written communication skills.Able to work independently and be flexible to changing priorities.Able to handle multiple projects in a fast-paced environment.Able to collaborate effectively in a multifaceted, cross-functional environment.Meticulous; must be detailed and organized in the handling of documents with solid organizational skills and ability to prioritize multiple tasks.Have hands-on working knowledge doing GxP risk assessments and compliance reviews with passion for embracing modern quality tools and agile approaches.SALARY RANGE
Benchling takes a market-based approach to pay. The candidate's starting pay will be determined based on job-related skills, experience, qualifications, interview performance, and work location. For this role the base salary range is:ZONE 1: $118,320 to $160,080ZONE 2: $110,075 to $148,925ZONE 3: $106,505 to $144,095To help you determine which zone applies to your location, please see this resource. If you have questions regarding a specific location's zone designation, please contact a recruiter for additional information.Total Compensation
Total Compensation includes the following:Competitive salary and equity.100% premiums covered for health, dental, and vision for employees.Fertility healthcare and family-forming benefits.Four months of fully paid parental leave.401(k) + Employer Match.Commuter benefits.Home office stipend.Mental health benefits + Wellness stipend.Learning and development stipend.Generous PTO.Company-wide Summer & Winter holiday shutdown.Sabbaticals for 5-year and 10-year anniversaries.Diversity and Inclusion
Benchling welcomes everyone. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. We are an equal opportunity employer. That means we don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.For applicants for U.S.-based roles only: All new hires in the United States are required to be fully vaccinated against COVID-19 and to provide proof of vaccination prior to their first day of employment. If you are unable to be vaccinated for medical or religious reasons, we will explore potential reasonable accommodations; however, Benchling may not be able to grant such accommodations in all cases if doing so would cause undue hardship.
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