Regulatory Compliance Professional

3 days ago

Fremont, California, United States Fladger Assoc. Inc. Full time
Job Requirements

We are looking for a highly motivated and experienced Quality Assurance Engineer to join our team in Fremont, CA.

We offer a competitive salary of $140,000 - $200,000 per year, depending on experience.

About the Role:
  • This is an exciting opportunity for a Validation Specialist to manage and participate actively in all phases of qualification/validation for QC systems such as QC analytical instrument and equipment.
  • The successful candidate will provide guidance and technical information to stakeholders/customers, schedule activities and meetings with stakeholders/customers, and perform commissioning and qualification.

Key Responsibilities:

  • Manage and participate actively in all phases of qualification/validation for QC systems such as QC analytical instrument and equipment: commissioning/qualification, protocol execution, requalification, and decommissioning/retirement.
  • Provide guidance and technical information to stakeholders/customers.
  • Schedule activities and meetings with stakeholders/customers (e.g., to ensure timelines and milestones are on target, resolve/address reviewer comments on deliverables).
  • Perform commissioning and qualification (e.g., oversight/support of vendor qualification, compile Turn Over Package (TOP)).
  • Collaborate with vendor and internal maintenance and metrology departments for system onboarding and to establish calibration/maintenance plans (CAL/PM).
  • Generate/author system lifecycle documents (e.g., URS, CS, RA, Protocol, Report) and drive to approvals.
  • Execute qualification activities and analyze resultant data.
  • Author, review, and resolve execution discrepancies.
  • Generate/author/revise standard operating procedures (SOPs).
  • Update validation inventory list.
  • Support/provide guidance on QC system's Data Integrity gap assessments/data process maps; Review qualification/validation packages.
  • Support and/or assist with thermal mapping activities (e.g., for QC Controlled Temperature Units (TCU) such as freezers).
  • Track completion of Change Control actions.
  • Archive and/or scan paper-based execution packages for archival.
  • Participate and lead meetings with stakeholders/customers.
  • Collaborate with customers (e.g., System Owners/Data Owners) and stakeholders (e.g., QA) to drive validation deliverables (including change control actions) to completion and GxP release of QC systems.

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