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Quality Assurance Specialist

2 months ago

Spokane, Washington, United States Selkirk Pharma Full time
About the Role

This is a full-time, exempt position located in Spokane, WA. As a Quality Assurance Specialist at Selkirk Pharma, you will play a critical role in ensuring the company's adherence to regulatory requirements and industry standards.

Key Responsibilities
  • Manage and execute the Supplier Quality program by conducting external audits, evaluating supplier risk assessments, complaints and change notifications, and/or associated approvals.
  • Manage and execute the Compliance program by conducting internal audits, hosting client audits and regulatory inspections, and leading / supporting management review and risk management.
  • Manage and execute site inspection readiness by conducting preparation sessions, mock inspections, developing and maintaining storyboards, and management of compliance data.
  • Develop, plan, and conduct internal audits of Selkirk's functional areas ensuring compliance to regulatory requirements, expectations and internal processes and programs, write audit reports, review and track corrective actions and audit closures with escalation as necessary.
  • Serve as a cGMP consultant to internal and external clients and provides researched and supported opinions on complex compliance issues which will provide guidance to less experienced staff members.
  • Manage, support, and participate in regulatory agency inspections and client audits and lead cross functional teams to develop responses to observations and track the commitments to completion.
  • Support quality functions including Deviations, CAPAs, Change controls, development of key performance indicators, and continuous improvement initiatives.
  • Work cross functionally with all functional areas and provides support and guidance to ensure the site meets applicable global regulatory, cGMP and company requirements.
  • Support execution of Selkirk's regulatory strategy including Compliance, Operations, and Surveillance functions.
Requirements
  • Bachelor's degree in science or relevant field.
  • Seven (7) years' related experience in Quality Unit functions within a government regulated industry (FDA pharmaceutical manufacturing environment preferred), or an equivalent combination of education and experience.
  • Experience developing, executing, and managing Supplier Quality and Compliance programs.
  • Experience facilitating client and regulatory inspections, inspection readiness, and development and tracking of responses and commitments to regulatory observations.
  • Extensive knowledge of industry guidelines including cGMP and regulatory guidelines (i.e. FDA, EU, ICH, ISO).
  • Experience in quality of aseptic processes Grade A through Grade D production areas and knowledge of isolation technology with filling operations experience highly desired.
  • Professional ASQ Certified Quality Auditor certification preferred, or willingness to obtain.
  • Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.
  • Experience utilizing QMS software preferred, such as Trackwise, Master control, Vevva, etQ Reliance, Dot Compliance.
  • Working knowledge of Virtual Manufacturing Software preferred, such as ModaES, Master Control, Syncade, Detla V, and Electronic Batch Records.
What We Offer
  • Competitive salary range: $79,000 - $99,000 annually.
  • 160 hours of PTO (pro-rated based on hire date), 52 hours of sick time (pro-rated based on hire date), and 10 paid holidays.
  • Bereavement Leave: 5 days per event.
  • Paid Maternity/Paternity Leave - 160 hours per occurrence.
  • Health Benefits: Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&D.
  • Employee Assistance Plan: Counseling sessions, legal services, financial services, and more.
  • Prepare for the Future: Stock options and 401(k) with no vesting period (100% match on the first 3% and 50% on the next 2%).
  • When Duty Calls: Jury Duty that is. We offer up to 10 days per event.
  • Cell Phone Stipend: $10 per month.