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Manufacturing Compliance Specialist

3 months ago

Woodinville, Washington, United States Medix Full time

Qualifications

  • Minimum of associate's degree and/or equivalent combination of education and experience is required
  • 2+ years of experience in a GMP Quality or Manufacturing setting
  • Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulated environment
  • 5 more items(s)
Responsibilities
  • The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls
  • Additionally, the Manufacturing Compliance Specialist serves as a mentor to members of the operations team, providing training and guidance for compliance related activities
  • Primary driver of Manufacturing investigations for related non-conformances
  • 13 more items(s)
Job description

We are a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. We are led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

Employee benefit programs:
  • Medical, Dental, Vision, FSA, or HSA: Currently we contribute 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
  • 401(k) program: We contribute 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
  • Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
  • Paid Holidays: We offer 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company's Bonus and Stock Award Plans.
Summary: The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls. Additionally, the Manufacturing Compliance Specialist serves as a mentor to members of the operations team, providing training and guidance for compliance related activities.

Duties And Responsibilities:
  • Primary driver of Manufacturing investigations for related non-conformances.
  • Primary driver for Manufacturing change control requests
  • Primary Driver for GMP audit responses / CAPA development.
  • Reviewing of Manufacturing batch records and logbooks
  • Championing the quality philosophy.
  • Tracking and reporting KPIs; and driving continuous improvement efforts.
  • Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products.
  • Assistance with inspection readiness efforts and providing Inspection support as required.
  • Build partnerships with cross functional department teams.
  • Provide critical communications upward, downward, and across as deemed fit; manage compliance related decisions- acquire feedback, input, and consult as required.
  • Review and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
  • Ensure deviations, CAPA, change controls, and other business drivers are supported and completed in a timely fashion.
  • Driving right first time (RFT) culture within Manufacturing. Education: Bachelor's degree in related field is preferred. Minimum of associate's degree and/or equivalent combination of education and experience is required.
Experience:
  • 2+ years of experience in a GMP Quality or Manufacturing setting.
  • Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulated environment.
  • Experience working in a QMS
  • Adaptable to a fast paced, complex, and ever-changing business environment.