Validation Specialist
2 weeks ago
Fladger Assoc. Inc. is seeking a highly skilled Validation Specialist to join our team in Fremont, CA.
We offer a competitive salary of $120,000 - $180,000 per year, depending on experience.
About the Role:- This is an exciting opportunity for a Quality Assurance Engineer 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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