Specialist II, Quality Assurance Validation

Lonza-posted 3 months ago
Bend, OR
5,001-10,000 employees
Professional, Scientific, and Technical Services
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Lonza Pharma & Biotech is currently seeking a Specialist II, Quality Assurance for our team in Bend, Oregon. Here, you'll have the outstanding opportunity to work with world-class professionals in a collaborative environment that fosters innovation and excellence. You'll play a meaningful role in ensuring our products meet the highest quality standards, helping us to achieve flawless execution.

  • Review and approve method validation protocols, summary reports, stability protocols & reports, and related documentation for accuracy, completeness, and compliance with cGMP and regulatory guidelines.
  • Act as subject matter expert and ensure consistency in validation strategy/approach for analytical instrument qualification, and method validation.
  • Collaborate with Analytical Development, and QC groups to support method development/validation, analytical instrument qualification and lifecycle management of associated documents.
  • Review and assist in timely completion of validation discrepancy reports, change controls, investigations, and CAPA/ECs as applicable.
  • Participate in internal and external audits, & regulatory inspections providing subject matter expertise on method validation and QA processes.
  • Track and trend validation metrics to support continuous improvement initiatives.
  • Ensure timely QA oversight of analytical instrument qualification, stability program and method development, transfer & validation activities.
  • Knowledge of data integrity principles, system periodic review and audit trail review.
  • Controlled documents and records generation, review, and approval in systems like MasterControl, Documentum, Kneat and TrackWise.
  • Work with stakeholders to resolve and reduce potential risks from audits and inspection findings, and gap assessments.
  • Bachelor's Degree or equivalent experience in a scientific or related field is required
  • Experience in a GMP pharmaceutical or biotechnology industry
  • Proven track record with qualification and validation
  • Strong attention to detail and ability to work in a fast-paced environment
  • Excellent collaboration skills to work effectively across various functions
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