ROLE OVERVIEW

This position will play a key role in the 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 $160,080
  ZONE 2: $110,075 to $148.925
  ZONE 3: $106,505 to $144,095

To 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 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

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